Quality Program Manager - EAG Laboratories - St. Louis, MO

  • Full-time

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in Agroscience Contract Research Organisation services. One of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, Eurofins has an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

In this role, you will work together with operations to plan, coordinate, and maintain Quality Assurance in compliance with all policies, procedures, customer specifications, and regulatory requirements. You will work collaboratively with the laboratory management team to improve overall laboratory performance.

EAG Laboratories operates in accordance with International Traffic in Arms Regulation ITAR. Quality Manager must be a US Person (Citizen or Permanente Resident) as this person will be exposed to managing, sharing, safeguarding, and disseminating technical information in accordance with policy and law ( ITAR, 22 CFR §120-130).

Essential Job Functions:

  • Works closely with operations to ensure daily operations follow policies, procedures, customer requirements, and local, state, and federal regulations
  • Ensures escalation of non-conformance events to the proper operations and corporate QA personnel
  • Oversees all quality aspects work in St. Louis, this includes writing, reviewing, and issuing of quality documents, oversight of all projects, review and sign off of all quality records.  

Customer Specification Management

  • Participates in the review of new and revised versions of policies and procedures
  • Monitors compliance to customer specifications and communicates any issues/concerns
  • Works with operations to resolve any client concerns or complaints

Standardized Operating Procedures (SOP’s)

  • Ensures laboratory personnel have access to the most recent versions of the Corporate Standardized SOP’s and that all training records are current
  • Prepares laboratory specific versions of SOP’s as directed by the Director of Quality and Compliance
  • Ensures all forms and work instructions are linked to the laboratory SOP’s and are reviewed, revised, and updated annually

Auditing

  • Leads internal, customer, corporate, and FDA regulatory audit visits
  • Engages appropriate operations management to ensure audit responses are completed in the allotted time frame and sustainable corrective actions are identified, agreed to, and implemented within defined time lines

Customer/Consumer Complaints

  • Manages the laboratory investigation for all complaints
  • Ensures timely response and a thorough review of all records
  • Provides written reports to corporate QA Director
  • Conducts investigations into incidents and quality issues
    • Document findings, performs trend analysis, and communicates to management, employees, and customers as appropriate
  • Record Review:  Ultimate oversight to ensure all record review is current for laboratory, sanitation, and production documents
  • Facilitates scheduling and/or delivery of quality/safety training to meet corporate and regulatory requirements
    • Completes training as required, to maintain license and certifications required by the position
  • Maintains current knowledge through seminars and industry publications to develop skills and improve job performance
  • Protects confidential information and proprietary processes

Qualifications

  • 4+ years of specifically related experience or a combination of education plus related or applicable work experience. Experience includes quality or compliance management in a GMP and/or GLP setting.
  • Demonstrate technical expertise in Quality Management and experience in analytical service. 
  • Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. 
  • Knowledge of laboratory statistics may be necessary.
  • Ability to define and solve practical problems, present solutions, establish facts, and draw valid conclusions. Able to deal with a variety of concrete variables in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to read, analyze, and interpret professional journals, technical procedures, or government regulations. Able to read and interpret document such as study protocols, standard operating procedures, safety policies, instrument operation and maintenance instructions, and procedure manuals.  Able to summarize data and results. Able to write reports, correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and others

What would set you apart?

  • Experience with analytical chemistry and data interpretation is highly desirable.
  • Certification and Licenses a plus

We encourage you to apply even if your experience is not a 100% match with the position. We are looking for someone with relevant skills and experience, not a checklist that exactly matches the job description. We want to help you grow and in return, you will help us grow into a stronger, more inclusive organization.  

Physical Requirements:

  • Must be able to remain in a stationary position 50% of the time. 
  • The person in this position needs to occasionally move about inside the office or laboratory to access file cabinets, machinery, equipment etc.
  • Ability to continuously operate a personal computer or lab equipment for extended periods of time (4 or more hours).
  • Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate a keyboard and other lab equipment, use a telephone, access file cabinets and other items stored at various levels, including overhead   
  • Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting.
  • Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with visitors, ability to complete tasks in situations that have a speed or productivity quota.

The essential physical and mental requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.   

We will consider reasonable accommodations for qualified individuals with disabilities. If you have a disability or special need, we would like to know how we can better accommodate you.  

Additional Information

What It’s Like to Work Here:

Teamwork: be inspired by your leaders, be encouraged by your teammates, and be supported in all parts of your journey while you work with us.

Learning & Development: take on career development programs and goal setting to create big possibilities for your career and life. Develop within the company; be mentored and grow as a leader.

Diversity & Authenticity: we work hard to embrace diversity and inclusion and encourage everyone to bring their authentic selves to work every day.

Benefits & Perks to Foster Work/Life Balance:

✓ Medical, Dental and Vision Coverage

✓ 401k Company Matching

✓ Paid Time Off

✓ Wellness Program

✓ Education Assistance

✓ …and more!

Eurofins EAG Laboratories/Nanolab Technologies is committed to promoting an equal employment opportunity workplace environment and is an equal opportunity employer. It is the policy of the Company that all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, citizenship, pregnancy, genetic information (GINA), disability, military and/or veteran status, and/or any other status protected by applicable Federal, state, or local law.  The Company’s policy is to recruit, hire, train, promote and administer all employment-related matters based on an individual's qualifications, abilities and efforts without regard to protected status.  

Eurofins is a Gender, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.  

If you enjoy being immersed in technology, tackling problems head-on, finding solutions through teamwork, and taking pride in accomplishments, join us today! Check out our other opportunities: www.eag.com/about/careers/                     

Privacy Notice