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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It 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 Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer 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 aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
