Quality Assurance Specialist - EAG Laboratories - St. Louis, MO

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

• 2+ years of specifically related experience or a combinatio