Senior Quality Assurance Associate

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. Eurofins is 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, as well as having 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 2023, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

The Senior Quality Assurance Associate is responsible for administrative function, data reporting, document control, equipment control, auditing, regulatory compliance, stability, and manufacturing activities as needed.

• Start and stop work authority
• Supports admininistration function by:
  • Acting as the Deputy QAS/QAM in their absence
  • Monitoring quality systems deadlines and reports to management pending and overdue activities
  • Assisting with the PO system for the QA group o maintaining Analytical Subcontractor compliance
  • Writing, reviewing, and approving Events, CAPA, OOS/OOT and Change Control
  • Managing investigations
  • Writing, reviewing, and conducting Quality System, cGMP, and GLP training
  • Participating in data analysis and reporting
  • Serving as QA trainer, as needed
• Supporting sister sites(s) as required
  • Supports all Quality Assurance I and II roles for:
  • Auditing
  • Data reporting
  • Document control
  • Equipment control
  • Manufacturing (as required)
  • Stability (as required)
• Supports Auditing by:
  • Performing Internal audits per Standard Operating Procedure
  • Supporting and hosting client and regulatory audits
  • Conducting external audits
• Supports Regulatory Compliance
• Supports the Stability Program as needed by:
  • Reviewing and approving Stability Protocols
  • Reviewing Stability Chamber Pull Schedules
  • Reviewing and approving Stability Chamber mapping o monitoring and following up Stability Chamber excursions o other task as required
• Supports Manufacturing as needed by:
  • Executing and reviewing batch records
  • Quality assurance inspection and release of cGMP materials o reviewing, creating, and approving Batch Records
  • Reviewing, creating, and approving Certificates of Compliance
  • Conducting cGMP vendor qualification
• Other functions as assigned

Qualifications

• Required: 10 years in a GMP/GLP environment with 7 years in a QA role
  Required: Minimum of an Associate’s Degree
  Required: Understanding of FDA requirements and Quality Systems
  Required: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
  Preferred: Bachelor’s Degree in a scientific field

Additional Information

Position is full-time, Monday - Friday 8:00am - 5:00pm . Candidates currently living within a commutable distance of Cary, NC are encouraged to apply.

• 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.