QA Specialist III - Eurofins USA BioPharma Services

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 believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 55,000 staff across a network of more than 1000 independent companies in over 50 countries and operating more than 800 laboratories. 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, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.

 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.

Under minimal supervision, the Quality Assurance Specialist III will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. Candidates in this full-time, onsite, position will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits.

Essential Duties/Responsibilities:

• Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
• Maintain the internal auditing program to ensure the established techniques are followed and understood.
• Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings.
• Maintain the Management Review process.
• Maintain the laboratory proficiency testing program.
• Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.) and train
• laboratory personnel, as needed to help reduce quality events.
• Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings.
• Support quality event investigations to completion using formal root cause analysis tools.
• Support periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the QMS.
• Maintain the list of approved suppliers and subcontractors.
• Audits various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.).
• Serve as a site contact for all quality inquiries on analytical reports and related documentation.
• Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
• Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other site-specific Quality Assurance documents.
• Create, revise, review, and approve newly written documents and document revisions.
• Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements.
• Trains laboratory personnel in GXP/ISO procedures, practices, and guidelines.
• Exist as a backup for all other Quality Assurance personnel.

Education:

• A bachelor’s degree or higher in chemistry, biological science, or life sciences field 

Experience:

• 3-5 years of laboratory quality assurance experience.
• Must have experience working in a GMP facility.
• ISO 17025:2017 accredited lab experience preferred.
• Moderate understanding of microbiology and/or chemistry-related terms.
• Moderate understanding of USP/EP/JP standards and guidelines.
• Experience with testing of pharmaceutical, cosmetic, and/or medical device products.

Capabilities:

• Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills.
• Strong organizational skills, and ability to multitask in a dynamic, fast-paced
• environment.
• Displays sound judgment and ambition; is quality-focused; displays good communication skills; good implementation and follow-up skills.
• Hands-on experience and strong understanding of industry regulations and how to apply them including 21 CFR Part 11, 21 CFR Part 820, ISO 17025, USP, and GxP.
• Hands-on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ).
• Strong problem-solving skills include root cause analysis using formal RCA tools such as Ishikawa and 5Y's.

Hours are Monday - Friday  Candidates currently living within a commutable distance of North Brunswick are encouraged to apply.

What we Offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

• Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.