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April 28th, 2017

IRB Regulatory Coordinator Temp Needed in West Los Angeles

Growing Oncology Clinical Trial site needs a temporary IRB Regulatory Coordinator in the west side of Los Angeles. This is a contract position while the incumbent is on maternity leave.

Responsibilities:

  • Will provide support for clinical research protocols, informed consents, etc.
  • Will assist with all aspects of clinical research regulatory to ensure compliance to regulations and protection of human subjects
  • Prepare and submit documents to the IRB

Requirements:

  • Bachelor’s degree required
  • 1+ years of IRB/Regulatory experience required
  • Oncology experience is preferred
  • SoCRA or ACRP is preferred

What Do You Want To Do Next?

  1. Submit your resume /Contact Paul
  2. Download Six Tips for Investigating an Employer
  3. Search more jobs
  4. Learn how to Build a Happy Team
  5. Speak with someone about my staffing needs
  6. Learn about our full-time recruiting services

Contact Paul/Submit Your Resume

Paul Dionne
Talent Manager
MEIRxRS
pdionne@meirxrs.com 818-552-2625

Fill out my online form.
April 28th, 2017

Regulatory Affairs Project Manager Job – Medical Device

Our client needs a Regulatory Affairs Project Manager  to support Asia Pacific (Japan, China, South Korea and Taiwan) regulatory approvals for implantables. Comfort and experience working hands on with design and validation reports and other technical files is needed.

Requirements

  • Previous experience authoring or approving design and validation reports a plus (strong technical writing skills).
  • Experience in Regulatory Affairs with US Class III cardiovascular devices strongly preferred.
  • Experience working with registration partners.
  • 510(k) experience and PMA experience a plus.

Major Duties

The Regulatory Affairs Project Manager will report to the Manager of International Regulatory Affairs.

  • Manage the preparation and maintenance of high quality filings to clearly documented, established timelines, including but not limited to: Letters to File (LTFs); investigational use applications and annual reports; marketing applications and annual reports to US and international regulatory authorities.
  • Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate.
  • Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidances and ensure effective communication to the project teams and management.
  • In conjunction with international regulatory partners (internal and external) and Regulatory Management, develop, justify, and document sound regulatory strategies to support corporate goals in identified regions globally.
  • In collaboration with the international regulatory team, manage interactions with international agents and distributors to clearly identify regulatory requirements and changes on an ongoing basis.
  • Directly interact with regulatory bodies in the US and internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible.
  • Assign and oversee completion of prioritized tasks to Regulatory Affairs specialists as appropriate.
  • Review and approve document change orders (DCOs), technical documents, test protocols and reports, risk management documents, and other documents as a key member of the project teams.
  • Manage query resolution process using sound project management skills and to agreed upon timelines in collaboration with cross-functional technical teams.
  • Coordinates with RA international staff and internal support staff to support basic file preparation as needed.
  • Update departmental procedures
  • Prepare high quality presentation materials and training materials to meet project objectives and for internal and external communication.

The Regulatory Affairs Project Manager title is equivalent to the Principal Regulatory Specialist title.

What Do You Want To Do Next?

  1. Submit your resume /Contact Paul
  2. Download Six Tips for Investigating an Employer
  3. Search more jobs
  4. Learn how to Build a Happy Team
  5. Speak with someone about my staffing needs
  6. Learn about our full-time recruiting services

Contact Paul/Submit Your Resume

Paul Dionne
Talent Manager
MEIRxRS
pdionne@meirxrs.com 818-552-2625

Fill out my online form.
April 25th, 2017

Medical Monitor Oncology Job (US-Based Remote)

We have a medical monitor oncology job for a doctor with experience in clinical drug development. The doctor will help our foreign-based client with their US clinical trials. Work is estimated to take 20 hours per month to start.

Requirements

  • Medical Doctorate (MD) or equivalent
  • 5 years clinical drug development experience in oncology
  • Phase 1 and phase 2 studies

Responsibilities

1. Available to clinical investigator sites as a go-to person in the US for checking eligibility

2. Be responsible for interacting with sites on safety management of the study. This will include but not limited to evaluation of serious adverse events, adverse events of special interest, discussions with sites on causality assessments, requesting clarifications on safety data and ensuring that information collected in the prescribed forms or data bases is complete.

 

What Do You Want To Do Next?

  1. Submit your resume /Contact Paul
  2. Download Six Tips for Investigating an Employer
  3. Search more jobs
  4. Learn how to Build a Happy Team
  5. Speak with someone about my staffing needs
  6. Learn about our full-time recruiting services

Contact Paul/Submit Your Resume

Paul Dionne
Talent Manager
MEIRxRS
pdionne@meirxrs.com 818-552-2625

Fill out my online form.
April 5th, 2017

Global Pharmaceutical Labeling Manager – Contract position in Irvine CA

pharmaceutical labeling of drug bottlesOur client needs a Contractor to work as Manager of Global Pharmaceutical Labeling. Contract is estimated for 12 months at their facility in Irvine, CA. Possibility for conversion to full-time after a year. We offer benefits including employer contribution to healthcare for this position. You must have authorization to work in the United States (sponsorship is not available).

Requirements – Must Have!

  • Bachelor’s degree in a related scientific discipline with a minimum of 4 years related experience within a pharmaceutical company, CRO or similar organization. 
  • Or Masters, PharmD or PhD with minimum of 2 years’ experience. 
  • Experience drafting and reviewing pharmaceutical labeling and compiling supportive documentation, and demonstrated competence in marketed product labeling maintenance.
  • Live within commuting distance to Irvine, CA

Additional requirements

  • Basic knowledge of global core data sheet guidance and US regulatory labeling requirements. Relevant experience may include a background in Drug Regulatory Affairs (i.e., FDA liaison) with experience in interpretation of FDA regulations, including exposure to labeling development and maintenance, or a background in medical writing with exposure to FDA regulations as a guide in content development for medical and/or regulatory documentation.
  • Detail-oriented, well organized and good planning skills.
  • Ability to manage multiple projects and deadlines.
  • Ability to exercise independent judgment yet identify compliance risks and escalate whennecessary.
  • Excellent proofreading/editing skills are required
  • Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
  • Excellent computer skills required

Main Areas of Responsibilities

  • Facilitate Core Pharmaceutical Labeling Review Committee and US Labeling Review Committee meetings for assigned marketed or development product, ensuring the timely distribution of preparatory documentation, identification of issues for discussion, preparation of meeting minutes and follow-up of action items to complete resolution. Provide strategic Labeling guidance to authors regarding appropriate content for Company Core Data Sheets, FDA regulations, and FDA guidance.
  • Assist in the development and review of international local labeling in accordance with the Company Core Data Sheet
  • Interact with business partners and provide strategic guidance as appropriate to ensure consistency and compliance of product labeling.
  • Manage outside vendor conversion of package inserts from MS Word or PDF to SPL format. Convert existing package inserts into Physician Labeling Rule (PLR) format, as needed.
  • Coordinate preparation of regulatory labeling submissions initiated by Regulatory Affairs with contributing functions in other departments.
  • Review for completeness, consistency and accuracy of proposed changes and supportive documentation, making recommendations or suggestions back to the Project Teams or Regulatory Strategists as appropriate.
  • Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidance.
  • Assist with training of Regulatory Affairs and other functions re: labeling processes as appropriate.
  • Maintain knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.

What Do You Want To Do Next?

  1. Submit your resume /Contact Paul
  2. Download Six Tips for Investigating an Employer
  3. Search more jobs
  4. Learn how to Build a Happy Team
  5. Speak with someone about my staffing needs
  6. Learn about our full-time recruiting services

Contact Paul/Submit Your Resume

Paul Dionne
Talent Manager
MEIRxRS
pdionne@meirxrs.com 818-552-2625

Fill out my online form.
April 3rd, 2017

Human Resource Accounting Assistant job openings

Human Resource Accounting Assistant job openingsBoutique search agency in Glendale, CA seeks hiring for the first of multiple Human Resource Accounting Assistant job openings. We need someone part time who can become full time as we fulfill the needs of new clients.

Requirements

Both: 1-2 years experience in Human Resources and 1-2 years experience in Accounting
QuickBooks
BA/BS degree preferred

Hours: 
Monday and Wednesday 8:30 am-5:00 pm (3 months-90 days)
Monday-Friday 8:30 am-5:00 pm
(one half hour paid lunchtime; 2 – 15 minute breaks)

Job Description

Human Resources: Assist in processing new hire paperwork; employee benefits, insurance and taxes; liaison to all internal and external employees
Accounting/Payroll: A/P, A/R, payroll, taxes, quarterly and year-end reports; reconcile invoices and statements; scan and electronically file documents; working knowledge of Quick Books, Adobe Acrobat, Outlook, Word and Excel
• Other duties as assigned: process government reports (we have Federal and State funding), grants and GSA contracts
• Candidates living within 5 miles of the City of Glendale are preferred

Pay and Benefits

Base dependent on work experience and references
Full time benefits: medical insurance, paid time off, paid holidays, discretionary merit bonuses

About

MEIRxRS provides talent solutions such as Executive SearchRecruiting and Staffing for life sciences companies. Our foundation also provides bioscience apprenticeships.

Apply with Indeed for Human Resource Accounting Assistant job openings

Apply Directly for Human Resource Accounting Assistant job openings

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March 28th, 2017

Your Staffing contractors now have general liability insurance for up to $10 million

General Liability Insurance reduces risks to your financesWe have increased our general liability insurance coverage for contractors, temps and temps to hire from $2 million to $10 million to better serve our customers. Additionally, we are carrying an additional $2 million for Errors and Omissions – after all there is nothing more expensive than bad data.

One of the pitfalls to hiring a 1099 contractor is that most likely, they do not have general liability insurance, which protects you, their client, and ensures their business continuity. Should they inadvertently damage your equipment or data, you will have to make a claim against your own insurance policy, if possible.

What is General Liability Insurance

General Liability Insurance is a part of the general insurance system of risk financing to protect the purchaser (the “insured”) from the risks of liabilities imposed by lawsuits and similar claims. It protects the insured in the event he or she is sued for claims that come within the coverage of the insurance policy.General liability insurance covers negligence, property damages, personal injury, advertising injury, electronic data, defense costs and possible loss of business.

The Solution

Make sure your 1099s have insurance by putting them on a staffing contract through us. They will get W2s, be eligible for benefits and be covered under workers’ compensation. This will also help avoid an Employment Development Department (EDD) Audit.

Contact us today!

Fill out my online form.
March 24th, 2017

FSPCA FSMA Training, June 2017, Cal Poly, Pomona, CA

Four reasons to take FSPCA FSMA Training:

  • FDA requires food companies with more than $1M in revenues have a plan by September 19, 2017
  • Plans must be signed off by someone with a FSPCA certificate
  • Writing a plan is a 5-6 month process
  • The learning manual is 526 pages long

Avoid getting into compliance too late.

FSPCA FSMA Training Attenddes

Attendees of our March FSMA training at NOAA

bfor Human Foods will earn you your certificate to be a Preventive Controls Qualified Individual (PCQI) as required by the FDA. It is a 20-hour offered through our Foundation and hosted by Cal Poly Pomona. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.

WHEN Wednesday, June 21, 2017 at 7:30 AM – Friday, June 23, 2017 at 1:00 PM (PDT)

WHERE: California State Polytechnic University, 3801 W Temple Ave, Bldg 4, Room 2-314, Pomona, CA 91768
Read the rest of this entry »

March 17th, 2017

GVP Pharmacovigilance Audits – Senior GVP Audit/Project Manager Needed

Our client needs a full-time Senior GVP Audit/Project Manager to handle their GVP Pharmacovigilance Audits. This person will plan and perform domestic and international GVP audits to assess the company’s compliance to local and international government regulations. They will also assess internal SOPs as they relate to GVP Quality Assurance and regulatory compliance. This position is located Read the rest of this entry »

March 14th, 2017

Avoiding an Employment Development Department Audit

Download the list of Employment Development Department trigger

The Employment Development Department (EDD) conducts payroll tax audits of businesses operating in California. Here are some triggers that cause a company to get audited:

  1. The 1099 independent contractor (IC) files an unemployment claim. This creates suspicion because ICs are NOT eligible for unemployment.
  2. The 1099 IC files a workers’ compensation or disability claim against the company. If someone is truly an IC, they should carry workers’ comp and disability insurance on themselves because they are not eligible through an employer.
  3. A worker receives a W-2 and a 1099 Form from the same employer in one year. This happens when they are converted from a 1099 IC to a direct hire of the company. But if they performed the same work as a 1099 IC and a W-2 employee, the IRS may wonder why they were not classified as an employee all along. Read the rest of this entry »
March 3rd, 2017

Clinical Research Project Manager Needed – Remote Work

Clinical Research Project Manager needed by our client to manage clinical development projects to ensure on time regulatory submission.

Requirements

  • Bachelor’s-level degree required in science/health related field.  A Master’s degree is a plus.
  • Five years clinical research and/or clinical project management experience.
  • A thorough understanding of GCPs and FDA and ICH guidelines is essential.
  • Must be willing to travel up to 20%.

Read the rest of this entry »

March 2nd, 2017

Clinical Operation Manager Needed, Remote / Work from Home

Clinical Operation Manager needed by our client to co-ordinate clinical study design and implementation at a program and functional level according to Good clinical practice (GCP).

Clinical Operation Manager Qualifications

  • Position requires a minimum of a Bachelor of Science degree and at least 5 years of clinical study management experience, including at least 2 years of phase III study management experience (7 years of clinical management experience for Sr. Manager or graduate level education with at least 3 years of clinical study management experience) in clinical research within a pharmaceutical or biotech environment or relevant CRO experience.
  • Experience working in therapeutic areas in ophthalmology will be a plus.
  • Good understanding of clinical study implementation process.
  • Willingness to travel up to 30%, as necessary, consistent with study or functional needs.

Read the rest of this entry »

February 17th, 2017

Oncology Medical Writer Needed, Remote Work

Our client is in need of an experienced oncology medical writer. The medical writer will translate the scientific hypotheses of clinical trials into lay terms for patient population and patient navigators. Ideally, you have experience in consumer-facing communication.

The client is developing software to better match stage Read the rest of this entry »

February 10th, 2017

QA Engineer – Medical Devices & IVD Manufacturer, Los Angeles, CA

QA Engineer needed to manage the selection, qualification, and monitoring of suppliers including finished device, OEM, and contract manufacturers. This person will play a key role in working with suppliers to resolve quality issues (SCAPAs), resolving internal non-conforming product issues, addressing incoming inspection challenges, including development and review of inspection procedures, overseeing equipment calibration, maintenance and validation, and maintaining accurate and complete documentation of these activities in compliance with the requirements of the Quality System Regulation (21 CFR 820) and ISO 13485.

Requirements

  • B.S. in in a technical discipline (i.e. science or engineering)
  • Five or more years of relevant experience in an FDA regulated industry
  • 3-5 years of which is in Quality Assurance
  • ASQ Certification as Quality Engineer (CQE) or equivalent, preferred

Read the rest of this entry »

February 7th, 2017

FSPCA FSMA Training, March 2017, Anaheim, CA

FSPCA FSMA Training for Human Foods will earn you your certificate to be a Preventive Controls Qualified Individual (PCQI) as required by the FDA. It is a 20-hour offered through our Foundation and hosted by Rentokil North American. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.

WHEN Wednesday, March 22nd, 2017 at 7:30 AM – Friday, March 24, 2017 at 1:00 PM (PDT)

WHERE: Rentokil, China Lake Training Room, 305 N. Crescent Way, Anaheim, CA 92801- View Map

Earn a Certificate of Training from Food Safety Preventive Controls Alliance Read the rest of this entry »

February 3rd, 2017

Senior Regulatory Affairs Associate

(Chicago Area, IL)

 

Summary:

This position is ideal for Ideal for someone looking to lead Regulatory strategy at the company’s facility located in the Chicago area.

 

This Regulatory Affairs Professional will be responsible for:

February 1st, 2017

Laboratory Assistant – Medical Devices & IVD Manufacturer, Los Angeles, CA

Laboratory Assistant needed to perform routine equipment maintenance, assure adequate stock and labeling of laboratory reagents and consumables, manage chemical and biological waste, sanitize lab surfaces, and monitor environmental controls.

Requirements

  • B.S. in Chemistry, molecular biology or biological sciences
  • 1-4 years hands-on experience in a regulated, laboratory environment
  • Knowledge of GLP, CLIA and HIPAA regulations governing handling and testing of patient samples in a clinical lab
  • Knowledge of safety precautions required for working with blood borne pathogens
  • Medical background preferred which includes medical terminology applicable to a clinical laboratory

Read the rest of this entry »

January 28th, 2017

VP Clinical Development – Rare and Orphan Diseases

VP Clinical Development for a small clinical-stage pharma company in Los Angeles San Fernando Valley. Candidate needs to have a MD, be experienced in rare and orphan disease studies and have significant experience clinical trials.

 

Requirements

  • M.D. or D.O. with specialty training, preferably CNS diseases
  • 10 -15 years of progressive experience through all the phases of drug development would be ideal
  • Management of clinical trials (Phases 1 – 3)
  • Experience in orphan and rare diseases, pediatrics and/or neurology preferred

Read the rest of this entry »

January 26th, 2017

Product Development Engineer- Medical Devices & IVD Manufacturer, Los Angeles, CA

Product Development Engineer needed to oversee the development and manufacture of low cost, plastic devices including disposable blood collection devices.

Requirements

  • At least 5 years of experience in the development of medical devices
  • Bachelor’s degree in an engineering discipline preferred.
  • Mechanical and/or electrical engineering background
  • Experience in manufacturing, development, project management or commercial roles in a regulated (FDA, ISO) manufacturing environment.
  • Computer aided design (CAD) / SolidWorks or similar software package

Additional Expertise: Knowledge & Skills

January 24th, 2017

VP Genomic Research, Los Angeles CA

VP Genomic Research needed to manage operational and logistical tasks of genomic test development to ensure efficient execution of studies for molecular diagnostic products within established budgets and timelines, ensuring all activities occur in compliance with the appropriate regulations.  The candidate will be responsible for designing the test development process, directing a team of molecular biologist, computational biologists, and clinical scientists. Read the rest of this entry »

January 23rd, 2017

Director of IVD Manufacturing and Supply Chain

Director of IVD Manufacturing and Supply Chain needed for an in-vitro diagnostics (IVD) client in Los Angeles, CA. The role is responsible for working with Product Development to select and manage key suppliers. Work alongside management and sales to establish forecasts and delivery schedules for key materials. This role will also negotiate Supply Contracts and assist in Read the rest of this entry »

January 21st, 2017

VP Clinical Affairs needed in Los Angeles, CA

VP Clinical Affairs needed to develop and implement clinical studies and molecular diagnostics validation strategy. The VP will coordinate the efforts of internal and external resources to ensure fast patient recruitment, trial site selection, trial plan optimization, and execution of trials with a focus on data quality. The candidate must be Read the rest of this entry »

December 6th, 2016

Preventive Controls Training (PCQI) for Human Foods CFR 21 Part 117

Preventive Controls Training for Human Foods will earn you your certificate to be a Preventive Controls Qualified Individual (PCQI) as required by the FDA. It is a 20-hour offered through our Foundation in addition to the Port of Los Angeles and the National Oceanic and Atmospheric Administration. Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.The Preventive Controls training for PCQI will be held at NOAA in collaboration from the Port of LA

WHEN Wednesday, February 22nd, 2017 at 7:30 AM – Friday, February 24, 2017 at 1:00 PM (PDT)

WHERE: NOAA, 501 W Ocean Blvd, Room 3470, Long Beach, CA 90802- View Map Read the rest of this entry »

October 12th, 2016

Southern California Quality Conference 2016

Southern California Quality Conference 2016 Logo

MEIRxRS CEO Rosemarie Christopher will be a speaker and have a booth at the Southern California Quality Conference 2016 (View Rosemarie Christopher’s profile View Rosemarie Christopher's LinkedIn profile).

Lewie Casey, our Talent Manager for Quality and Regulatory Affairs will also be present (View Lewie Casey’s profile View Lewie Casey's LinkedIn profile).

Whether you are interested in finding talent to build your quality team, or interested in advancing your own career in Quality, feel free to link to Rosemarie or Lewie and Read the rest of this entry »

October 11th, 2016
ASQ booth was stationed by Connie Chan, Mary Thorsness and Sumita Som (author of this FDA 483 Trending Topics & Solutions Recap) at the 2016 joint networking event with PDA

FDA 483 Trending Topics & Solutions Recap

The FDA 483 Trending Topics & Solutions Recap was written by Sumita Som about the Joint Networking Event: ASQ, PDA and SoCalBio for ASQ’s Food, Drug and Cosmetic division, who helped sponsor the event.

See the presentations:

This was my first time attending the ASQ -FDC -PDA -SoCalBio joint networking event on 6 October 2016 in beautiful Irvine, California.  The event was introduced by Ruchika Raval (PDA), Brian Underhill (SoCalBio) and event moderator Michael Hamrell. This was followed by the speakers and panel members: Marlene Garcia Swider, Barbara Uger, and Susan Bain, sparked Read the rest of this entry »

September 27th, 2016

Top 25 Biotech Companies – Career Search

The Top 25 biotech companies have convoluted career sites. It is frequently difficult to find where to search jobs and often more complicated than it needs to be.

Career Search All of Them at Once

Genetic Engineering and Biotechnology News (GEN) published a list of the Top 25 Biotech companies. Their list is based on total market capitalization. Interested in searching for your next job at these top companies? Use our search engine below. Tweet: Easier way to #jobsearch the top 25 #biotech companies. Use this search engine http://ctt.ec/5bi74+ @meirxrs #clinicalresearch #pharma It only includes career pages of the companies that made GEN’s list*.
Read the rest of this entry »

September 23rd, 2016

ASQ CHA Certificate Review Workshop 2016

ASQ CHA Review Workshop is scheduled for Friday, September 30, 2016 from 7:30 AM to 5:00 PM (PDT) at USDC NOAA Office of International Affairs and Seafood Inspection, 501 West Ocean Blvd, Long Beach CA

About the Workshop

The Bureau of Labor Statistics published its first Data on Certificates and Licenses. They note that those who hold a license or certification earn one-third more than those who do not. And holders are less likely to be unemployed.

If you are ready to take the next step in your quality career consider becoming a Certified HACCP Auditor (CHA) . Come and join us for a full day CHA/CQIA  Exam Review Workshop for only $99! Read the rest of this entry »

September 20th, 2016

Money Flows Back Into Biotech & PharmaMoney Flows back into life sciences for those looking for funding.

Money flows into life sciences appears to be on the rise.

This past February’s Biotech crash had a ripple effect for many companies. For example, following the crash, clinical trial starts dipped. This is according to CRO Activity Report 2Q 2016 report issued by BioPharm Insight. As an Executive Search firm with an eye out for opportunities where our candidates can make a big difference in pushing science (and investor returns) forward, this downturn has been disconcerting. Read the rest of this entry »

August 31st, 2016

FSMA Preventive Controls for Human Foods CFR 21 Part 117

FSMA Preventive Controls for Human Foods is a 5-week class offered at Miramar college starting Wednesday, October 5th from 9am-2pm.  Attendees of the class will earn a certification to become the Qualified Individual for the United States Food & Drug Administration (FDA) regulation on Preventive Controls for Human Foods.

WHEN Wednesday, October 19, 2016 at 9:00 AM – Wednesday, November 16, 2016 at 1:00 PM (PDT)

WHERE San Diego Miramar College – 10440 Black Mountain Road, San Diego, CA 92126 – View Map

Earn a Certificate of Training from Food Safety Preventive Controls Alliance

Read the rest of this entry »

August 29th, 2016

Joint Networking Event: ASQ, PDA and SoCalBio

Thursday, October 6, 2016 from 4:00 PM to 8:30 PM (PDT), Hilton Irvine/Orange County Airport, 18800 MacArthur Boulevard, Irvine, CA 92612

FDA 483 Trending Topics and Solutions

Joint Networking Event with PDA, ASQ and SoCalBio
  • Keynote: Dr. Marlene Garcia Swider, FDA Quality System Manager
  • Technical Session: FDA 483 Trending Topics and Solutions
  • Table-top Exhibits
  • Speed Networking
  • Western Theme (including Best Cowboy Attire contest)
  • Gourmet Buffet, Wine & Beer, Cash Bar
  • Raffle Prizes
  • transport from San Diego, Los Angeles and Thousand Oaks

Read the rest of this entry »

August 24th, 2016

Compliance of the Dietary Supplement Industry

Event at FDA Los Angeles District Office, Irvine CA on Thursday, November 17, 2016 at 7:30 AM – Download a PDF Flyer of the Dietary Supplements Industry Compliance workshop

Overview

Compliance of the Dietary Supplement Industry is critical under FSMA
It has been more than 6 years since the final implementation of 21CFR Part 111. We continue to see warning letters issued by the FDA to the industry for non compliance with the regulations.

This is a clear indication that there is still a need for better understanding of the regulations and alignment between the agency and the industry. And now we have FSMA (Food Safety Modernization Act), signed into law by President Obama in January 4, 2011. FSMA Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in  Read the rest of this entry »

August 19th, 2016

Oncology Research Nurse

An Oncology Research Nurse is needed by our client in Santa Monica, CA. Candidate should have experience in Oncology and wants grow by serving patients enrolled in clinical trials. Read the rest of this entry »

August 3rd, 2016

Business Development / Sales -Cardio Medical Devices

Business Development, Sales Manager, or Account Manager with more than 5 years of experience selling to the cardiovascular medical device industry needed. The position calls for someone to sell auditing and testing services to medical device companies. The candidate should demonstrate they have built a book of business within the medical device industry and increased revenues. Read the rest of this entry »

August 1st, 2016

FSMA Compliance Workshop 2016

Thursday, September 22, 2016 from 7:00 AM to 2:30 PM (PDT)

Supplier Verification Plan of FSMA (Food Safety Modernization Act) & Supplier Risk Management, Controls and Audits

FSMA will impact your food business. Find out how and what to do about it. This is a free half day workshop on Food Safety and Modernization Act (FSMA) compliance.

Breakfast and refreshments are sponsored by the American Society for Quality (ASQ) Food, Drug & Cosmetic Division, the Quality Leaders Network (QLN) Food Group, RxRS Apprenticeship Program.

Event Ended

Recap / Downloads / Presentations

Agenda FSMA Compliance Workshop 2016

July 12th, 2016

Clinical Research Services

Clinical Research Services help optimize your development timelines, whether your company is developing a biologic, drug or medical device. We offer a range of services to help you achieve your objectives.

We have separate legal entities (staffing, recruiting and CRO). Each helps you solve your Read the rest of this entry »

June 27th, 2016

Brexit and Biotech

Brexit and Biotech don’t mix.

Graph of Brexit and Biotech vs Dow

While the the biotech index is more volatile than the Dow normally, there is a sharper decline today. This is a reflexion of how Biotech will be impacted by Brexit Tweet: a reflexion of how #Biotech will be impacted by #Brexit http://ctt.ec/k24Ua+ #clinicalresearch #clinicaltrials :

  • London is a popular IPO market for many biotechs
  • Some US biotech IPOs have launched in Europe
  • European Medicines Agency (EMA) headquarters is in London
  • Brexit may impact EU companies looking to raise Read the rest of this entry »
June 20th, 2016

CE Marking Roadshow Comes to SoCal

Akra and von Hahn will speak about CE MarkingCE marking approval in Europe is being influenced by new regulations. These medical device regulations are replacing the current CE requirements outlined in medical device directives that dictate how your product achieves a CE mark.

For more information visit TÜV SÜD Roadshow events


Irvine CA Event Details

 CE Marking Approval in Europe – Irvine 

Organizer:  TÜV SÜD MHS 

Date Time:  August 10, 2016 ,   8:15 AM

Duration (hours) 04

Location:

Avenue of the Arts Costa Mesa  3350 Avenue of Read the rest of this entry »

June 17th, 2016

Staffing Agency Fees

Staffing agency fees include base pay, taxes, benefits and overhead. Staffing Agency Fees are Based On Employee Pay and Benefits shown in chart

 

Using data from March 2016, the Bureau of Labor Statistics (BLS), the average US employee earned earned $23.25 per hour. Employee benefits cost employers $10.70 per hour for a total of $33.94 per hour.

Staffing agencies usually quote their fees as a multiplier of the employee’s base pay.   The BLS data demonstrates that the first 1.46 of staffing agency fees covers wages, taxes and benefits ($33.94/$23.25 = 1.4597).

Agencies typically charge between 1.65 and 2.10 times the Read the rest of this entry »

June 16th, 2016

Biotechnology Jobs vs Biotechnology Careers

Biotechnology jobs are for short-term goals.

Biotechnology careers include your long-term goals. You can manage this journey through a combination of education, certifications and experience. Only then can you arrive at the destination you are most interested in.

Biotechnology jobs includeClinical Trials, Clinical Research, Quality, Regulatory, and Medical Affairs, Engineering and Software. Research in food, pharmaceuticals, biologics, and medical devices are sometimes lumped in with biotechnology.Keywords for biotechnology jobs and biotechnology careers

 

Skip to Search for Jobs

 

Let’s begin your career progression with Read the rest of this entry »

June 8th, 2016

PRESS RELEASE

Rx Research Services receives US Department of Labor Certificate of Registration of Apprenticeship Program

Mentor Mas Hori and his Food Safety Apprentice Karnia recognized by RX Research Labor Certificate

Mentor Mas Hori and his Food Safety Apprentice Karnia

(May 30, 2016 Los Angeles, CA) STEM apprentices to get on the job training and employment as Microbiology Quality Control Technician Quality Control Technician, Regulatory Compliance Associates plus 6 more Apprenticeships in food and biotechnology industries

Imagining a shortened runway to professionalism in STEM employment in Read the rest of this entry »

May 20th, 2016

Good Manufacturing Practice (GMP) Expo

The Good Manufacturing Practice (GMP) expo is being organized by the International Society for Pharmaceutical Engineering (ISPE) Los Angeles Chapter. Good Manufacturing Practice (GMP)

The event will be held:
Thursday, May 26, 2016
Brouwerij West
110 E. 22nd St.
Warehouse No. 9
San Pedro, Ca 90731

You can learn more and see the agenda at the ISPE LA website.

MEIRxRS will be there because we provide talent that contributes to good manufacturing practice. This includes our Executive Read the rest of this entry »

May 17th, 2016

Commercial Development Director / Sales (East Coast, West Coast, Europe)

The Commercial Development Director will set a road map for the sales team. The client is a Contract Manufacturer that provides bulk drug formulation and manufacturing. They also provide primary and secondary packaging capabilities for solid dose drugs. Their technologies include granulation, coating, blending, encapsulation, compression and drying of tablets and capsules.

Preferred Experience

  • Bachelor’s Degree Science/Business
  • Five plus years of selling in the Contract Manufacturing market
  • Operational Experience

Read the rest of this entry »

May 16th, 2016

Lab Apprentices —Building a Workforce in a Tight Labor Market

Lab Apprentices are now available for CLIA, CAP and 17025 labs in California.
Lab apprentices pipet

“We are pleased with [our apprentice] who has been valuable to effectively upgrade our quality control programs, bring a youthful vision and spirit to our workforce, and help us develop a competent team for the future,” said Kevin Kimura of Red Shell Foods, Inc. in Sante Fe Springs, CA.

We are hoping to bring the same satisfaction our food companies have to labs.

Quality is important in all industries, but it is particularly important in Read the rest of this entry »

May 13th, 2016

Director Account Management – Southern California

The Director Account Management will help establish pharmacies in clinics. Read the rest of this entry »

May 4th, 2016

Skype Interview Tips

Skype interview tips are covered in this great video by Matt Gnaizda.

These tips are great for online meetings too.

Watch it on YouTube: https://www.youtube.com/watch?v=rQwanxQmFnc

 

You only get one first impression. Skype has become the first impression that employers get of candidates. These interviews are being used it to whittle down the candidate pool for face to face interviews.

Matt walks you through four simple Skype Interview Tips to help you look Read the rest of this entry »

April 19th, 2016

Calculating the Cost of a Recall – 14 costs

Calculating the cost of a recall before it happens will help your executives understand how much to allot toward preventing a recall.

Calculating the Cost of a Recall - Value of Recalled Goods

Value of Recalled Goods 2014

You may think your company is under the government’s radar.

But, you are wrong!

Almost one-third recalls conducted in 2014 are from small companies under 5 employees.

Using data from the FDA and USDA we worked on calculating the cost of a recall. The average market value of products recalled in 2014 was $1,563,551 with a median of Read the rest of this entry »

April 13th, 2016

Clinical Research Staffing Agencies

Clinical Research Staffing Agencies cut the Time to Succeed

Clinical research staffing agencies cut the time for your clinical trials to succeed

Clinical research staffing agencies like MEIRxRS reduce your employment costs, reduce risk and increase flexibility.

Because balancing the demands of both your investors and FDA regulators isn’t easy.

We reduce your employment costs by allowing you to only pay for the skill set you need, with very little training or ramp-up time. And our thorough search process will ensure we find the talent required for your clinical trials to produce high-quality results for FDA approval.

Contracting offers tremendous Read the rest of this entry »

March 17th, 2016

Startup Incubator Labs in Southern California

Startup Incubator Labs are a great place for founders to build their pharma, biotech or medical device company. We’ve built a list of area labs for you. If you’re thinking to start your own business, looking to network with or do business with local startups use this list to find an incubator that’s Read the rest of this entry »

March 11th, 2016

Clinical Project Manager (Part-Time Contract ) – Philadelphia, PA

A Clinical Project Manager (part time contract) is needed for a Contract Research Organization (CRO) to work in their office in the Philadelphia area. This position will report directly to the Chief Medical Officer and includes responsibility for coordinating and managing all aspects of clinical study activities to maintain regulatory compliance and meet company timelines and goals for the clinical development program.  Looking for Read the rest of this entry »

February 2nd, 2016

Clinical Affairs Director – TX or Upper Midwest

Clinical Affairs Director will lead and manage the Clinical Affairs Department globally, reporting to Read the rest of this entry »

January 22nd, 2016

Personality Profiling: STEM Professionals in the New Economy

STEM Professionals need a range of skills to succeed in the new economy. Learn what key characteristics employers are looking for in technical hires.

ASQ Inland Empire Sections 706 and 711 will be profiling the STEM professional for the new economy that will be presented by our very own Rosemarie Christopher.

In this day and age, companies are being more selective as far as educational background, social media reputation, personality profiling and Read the rest of this entry »

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