Clinical Research Staffing stock photo

GMP Regulations for Friday the 13th

November 13th, 2015

GMP Regulations for Friday the 13th

Happy Friday the 13th! Remember, if you need a GMP or Quality specialist who knows the regulations below then don’t be scared. Call MEIRxRS.

United States – Food and Drug Administration GMP Regulations

Australia – Therapeutic Goods Administration

Canada – Health Canada


European Union – European Medicines Agency

India – Central Drug Standard Control Organization

Japan – Pharmaceuticals and Medical Devices Agency

Quality Apprenticeship Program Featured on

November 11th, 2015

Quality Apprenticeship Program Featured on

Quality Apprenticeship on website

Quality Apprenticeship on website

The State of California, Department of Industrial Relations has listed our two Quality Apprenticeships: Chemistry Quality Control Technician and Microbiology Quality Control Technician. These represent two out of the three apprenticeships available in the Health Services category.

The Division of Apprenticeship Standards (DAS) creates opportunities for Californians to gain employable lifetime skills and provides employers with a highly skilled and experienced workforce while strengthening California’s economy. MEIRxRS apprenticeship program supports this mission by requiring apprentices to work toward an industry certification while they are enrolled in the apprentice program. Each certification requires a mix of training and experiential learnings. Apprentices are paired with mentors who can provide guidance and support for the duration of the one to two year apprenticeship.

Our apprentices can be deployed in any FDA-regulated industry (food, biotech, pharmaceutical, medical device, nutraceutical, and cosmeceutical). Our grants cover the cost of training and mentoring the apprentice. If a mentor is not available within the host company, MEIRxRS will identify one.

The Quality Apprenticeship program helps businesses in multiple ways. Apprentices can help the company achieve a business objective. Currently, apprentices are helping small companies to comply with Food Safety Modernization Act (FSMA) regulations. Others are helping food companies pass third-party certification audits required to land new customers. To see apprentices in action watch the video on our FSMA page or read Four Ways to Use Apprentices to Improve Food Quality.

The apprenticeship program is designed to help military veterans, mothers returning to work, recent graduates and people coming off disability (such as cancer survivors) to return to the workforce.

What Do You Want To Do Next?

  1. Learn about the Quality Control Technician Apprentice Program
  2. Speak with someone about my staffing needs
  3. Learn about full-time recruiting services
  4. Submit my resume

Save the Date: SoCal Food Industry Conference March 2016

November 2nd, 2015

The 2016 Southern California Food Industry Conference theme will be Feeding A Hungry World: Knowledge, Nutrition, Compliance.

SAVE THE DATE – Outlook Calendar Item

March 10, 2016
8:30AM – 3:00PM

Disneyland Exhibit Hall
1150 Magic Way
Anaheim, CA 92802


Speakers Include:

  • Dominique Brossard, University of Wisconsin, Madison, On Science and Communications
  • Jim Painter, Sun Maid Growers Fats in Vogue, Wheat Woes, u-oh GMOs
  • TBD: Water Conservation

EVENT HELD IN CONJUNCTION WITH 2016 SCIFTS Suppliers’ Night Expo, which is an excellent opportunity to find new suppliers or showcase your own products.

March 10, 2016
3:30 p.m. until 8:00 p.m.

Disneyland Hotel Exhibit Hall
1150 Magic Way
Anaheim, CA 92802


Four Ways to Use Apprentices to Improve Food Quality

October 12th, 2015

Apprentices help reduce the risk of a recall, help pass third party certification audits, fix root causes of complaints, and reduce the cost of manufacturing. The impact on your business bottom line can be tremendous. Here are some ways apprentices are currently being used by our clients:

  • Apprentices can be used to pass third party certifications. This would allow you to land additional clients (make a list). Retailers and other manufacturers often require their suppliers to pass industry certification audits. This is because of the danger to reputation and bottom line that a recall by a supplier can have. The best example was the cumin recall where one supplier’s tainted product forced 38 other companies to recall their products, which used cumin-contaminated with peanut.
  • Apprentices can be used to reduce risks. The Blue Bell recall is a good case study. The issues identified in recall are ones that an apprentice, working toward an industry certification, could have easily identified. As was pointed out at the September 2015 FSMA workshop, it’s usually the small things like hand washing and clean bathrooms that trip companies up.
  • Apprentices can handle complaints, and use those complaints to identify correction/preventative actions (CAPA). An example how to calculate the cost/benefit of handling complaints is on our blog. The example highlights how most of your customers will not complain to you, but rather to an average of 28 of their friends and associates.
  • Company-wide certifications reduce complaints and long-term costs. In a whitepaper about certifying their facilities, US Foods and IFS demonstrate how their certification program reduced long term costs associated with handling complaints.


The apprenticeship program covers part of the cost of training and employing apprentices while they work toward an industry certification, typically one or two years. We focus on providing apprenticeships for military veterans, students, mothers returning to the workforce or individuals coming off disability. Apprentice positions include Quality Control, Regulatory & Compliance, Clinical Research, Biostatistics & Clinical Data Management, and Drug Safety.

What Do You Want To Do Next?

  1. Learn about the Quality Control Technician Apprentice Program
  2. Speak with someone about my staffing needs
  3. Learn about full-time recruiting services
  4. Submit my resume

FSMA Half Day Workshop Recap and Successes

October 7th, 2015
FSMA Food Safety Modernization Act

FSMA Food Safety Modernization Act insures the quality and safety of our food supply.

FSMA Attendees Give 4.6 Stars

Did you make the QLN FSMA half day workshop in Irvine? The 97 attendees seemed extremely satisfied with the Sept 24th, 2015 event, giving it an overall rating of 4.6 (scale 1-5).

Easy FSMA Launched

EasyFSMA website was launched by the Quality Leadership Network (QLN) members, which includes Rosemarie Christopher, our CEO. as a venue to disseminate information about the Food Safety Modernization Act (FSMA) and other pertinent topics.

Materials from the workshop will continue to be posted to EasyFSMA. The site includes the Food Corrective/Preventive Action Scorecard, by the ASQ metrics team ( The site also includes pictures from the workshop. Permission to re-post presentations has been requested of each speaker.

To be informed of future FSMA events, subscribe on

FDA Answers Your Specific Problem

FDA announced its page where you can submit specific problems your business is facing regarding FSMA (  FDA will route your question to an expert who will get back to you with guidance.

Apprenticeships for Food Quality

MEIRxRS showed a video on how its apprenticeship program is helping companies improve food quality. The video features how MEIRxRS client is using an apprentice to improve documentation and enforce cleaning procedures across shared equipment at incubator for food companies, Marimix. MEIRxRS also shared a link of other solutions for FSMA Compliance.

HACCP Auditor & Quality Improvement Associate Exam

October 2nd, 2015
ASQ Certified HACCP

Certified HACCP Auditor (CHA) and
Certified Quality Improvement Associate (CQIA)
Exam Review Workshops

Thursday, November 5, 2015

NOAA USDC Seafood Inspection Program
501 West Ocean Blvd., Long Beach, CA 90802


Are you ready to take the CHA or CQIA Exam? Come and join us for a full day CHA/CQIA  Exam Review Workshop for only $99! You will have the option to take the test the following day as long as you complete the CHA Exam Application DUE 10-16-15 (deadline extended)  or  CQIA Exam Application DUE 10-16-15 (deadline extended)  and email it with supporting documents and payment to by October 16, 2015.

Go to to get the CHA/CQIA Handbook at a discount when you register for the workshop and/or buy the handbook during this special event!


What Do You Want To Do Next?

  1. Register for the CHA & CQIA Exam Workshop, November 5, 2015
  2. Learn about the Quality Control Technician Apprentice Program
  3. Speak with someone about my staffing needs
  4. Learn about full-time recruiting services
  5. Submit my resume

Director of Quality (GCP) in San Diego, CA

September 30th, 2015

We have a client in Phase III Trials in San Diego that needs a Director of Quality. Candidates must have at least 4 years of experience in GCP to be considered.


Education, Requirements and Experience:

  • Strong applied knowledge of GCP, GLP and cGMP regulations & guidance
  • Management of FDA Inspections, including Pharmacovigilance/safety
  • 12-15 years of relevant experience;
  • BS Science; Advanced Degree preferred
  • Experience in a fast paced Biotech environment
  • Verifiable (through references) critical thinking and assessment skills
  • Influencer Leader- ability to get buy-in from cross functional groups
  • Experience in a commercial business with sensitivity to the pressures of a pre-ipo company



Lewie Casey

Talent Manager

MEIRxRS 818-552-4173

Contact Lewie/Submit Your Resume

Fill out my online form.

Five Tips for Assessing Your Next Employer

September 17th, 2015

Five Tips for Assessing Your Next Employer

How do you know if your next employer will be a good place to work? Use these tips to insure your next job is a step in the right direction.

Your investigation should attempt to uncover one of these pitfalls:

  • High turnover
  • Poor ethics
  • No Resources
  • Bad culture

Read the full article by MEIRxRS on

  1. Search LinkedIn for past employees & look at how many stayed for a long time and were promoted.
  2. Use InMail to ask for informational interviews from past employees.
  3. Read the corporate financials on Google Finance or Yahoo Finance.
  4. Read Reviews such as Yelp, Google and Better Business Bureau to see if customers are happy.
  5. Look for government actions such as investigations, audits, recalls, warnings, and consent decrees.

If you’re a CEO, CFO or board member, investigate your own organization. As the game of talent acquisition heats up, you don’t want to be left on the sidelines. Or contact us and request an assessment.

Clinical Planning Manager Job/Senior CTM, Large Pharmaceutical

September 8th, 2015
Sample Clinical Trial Timeline

Sample Clinical Trial Manager Timeline

Sr. Clinical Planning Manager

Large Pharma Client Needs Your Clinical Trial Expertise!

A Clinical Trial Manager, capable of handling 12 teams with 25 members each of both internal and external members, is urgently needed by our client. You will use your 8 + years of industry experience to proactively identify potential pitfalls and steer the team around them. You will clear roadblocks and insure all your team members have the resources needed to complete trials on time and right the first time.

Your deep knowledge of project management software will help you stay on top of critical pathways and help you balance your resources. You will likely have an easier time in this position if you have, or are prepared to earn a PMP certification. Your above average communication skills will help you convey the trial needs succinctly and your love of people will help you win allies and resources.

We are in communication with the Senior Vice President of Research. He has identified this position as critical to the success of the Division and taken a personal interest in seeing the position filled promptly. You will work directly with the Director of Clinical Planning.

If you already have experience as a Clinical Trial Manager managing multiple trials and you’re interested in learning more, please write to me at pdionne @ In about 300 words, let me know why this job is a great fit for you, not only in terms of your qualifications but also by answering the question “How will this opportunity advance your career?” For a full description visit

If you are a fit for the position, we will share more details about the client, insure your application and references are seen by the hiring managers and we will coordinate interview schedules. Your resume will be held in confidence and will not be shared without us receiving your permission.


FSMA Compliance Workshop, September 24, 2015

August 17th, 2015
FSMA Compliance Workshop

Download the PDF flyer

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 and Food Safety Net Services.


FSMA is designed to insure food quality from the farm to fork. FSMA requires all food manufacturers to have written and enforced GMPs, Sanitation SOPs, Hygiene Training Manuals, a HACCP Plan, Recall Plan and to upgraded labeling. Yet profit margins are thin for most food manufacturing companies while competition remains strong. To further complicate matters the supply-chain is fragmented despite the efforts of many manufacturers to simplify their recipes and reduce exposure to possible allergenic foods. The FDA is taking a Preventive Controls stance emphasizing ‘self-regulation’ so that they can support companies through educating while regulating. The net result is that the FSMA law requires manufacturers to insure compliance not just for themselves but also for all their suppliers.

Who Should Attend

Two representatives from each company are highly suggested.

  1. CEO, CFO, or VP of Finance
  2. Head of Quality (job description)

In the past, we’ve found that the workshops were informative for participants but when they went back to their offices, they had an up-hill battle getting buy-in from the financial decision makers. Especially, if support from multiple departments is required to implement changes, as is so often the case when improving Quality systems.

Companies with both representatives get first priority in attending this limited space workshop. With representation from both Quality and Finance, we can work to overcome objections and get greater buy in right there at the workshop. FDA gains an understanding of the constraints (financial, operational, technical, talent) that companies are facing. In turn, all this helps QLN Leadership to craft the message for reaching corporate decision-makers across the country and set realistic expectations.

There are a number of reasons for your executive or financial leaders to attend. Quality reduces the risk of costly recalls. Quality reduces customer complaints. Quality tools can reduce operating costs by eliminating waste and refurbishing. Quality can improve brand value. This is an opportunity to have a conversation with FDA, the very people with enforcement authority, about both the benefits and constraints your company faces with respect to Quality. If they are unwilling to spend a half day attending, it is unlikely you would be likely to succeed in getting buy in after the event is over.

FSMA Workshop Agenda

Hosted by: LA District FDA
• Presentations by:
o CFSAN Food Supplier Verification
Program (FSVP.)
o The State of California Food Drug
o FDA’s plan for implementing the
new FSMA law.
o What resources are available to
o What industries are in the
compliance priority list.
• Participate in real life case studies
about causes, effects and COSTS of

What Do You Want To Do Next?

  1. Register for the FSMA Compliance Workshop, September 24, 2015
  2. Learn about the Quality Control Technician Apprentice Program
  3. Speak with someone about my staffing needs
  4. Learn about full-time recruiting services
  5. Submit my resume
Logos of our membershipsmore Logos of our memberships