Job Information
Eurofins Quality Assurance Associate II in Cary, North Carolina
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.
Supports all Quality Assurance I roles as required
Supports administrative function by:
monitoring quality systems deadlines and reports to management pending and overdue activities
assisting in Analytical Subcontractor documentation maintenance
assisting with writing, reviewing, and approving Events, CAPA, OOS/OOT, and Change Control
writing, reviewing, and conducting Quality System, cGMP, and GLP training as required
Supports Data Reporting by:
reviewing, approving, and releasing laboratory data
reviewing, creating, and approving Certificates of Analysis
reviewing and approving Cumulative Reports, Protocols, Technical Reports and Summaries
reviewing and approving Methods
Supports Document Control by:
all Quality Assurance I roles
maintaining all Master Lists
maintaining Control of Specifications
assisting with writing and approving internal documents
Supports Equipment Control by:
maintaining identification and calibration labels/cards
reviewing and approving of preventative maintenance, verification, calibration, and qualification
maintaining records in LIMS
induction and decommissioning
Supports Auditing by:
performing Internal audits per Standard Operating Procedure
supporting client and regulatory audits as needed
Supports Stability as needed by:
reviewing and approving Stability Protocols
reviewing Stability Chamber Pull Schedules
reviewing and approving Stability Chamber mapping
monitoring and following up Stability Chamber excursions
Supports Manufacturing as needed by:
executing and reviewing batch records
Quality Assurance inspection and release of cGMP materials
Other functions as assigned
Required: a minimum of High School Diploma or Equivalent. Preferred Associate’s Degree and/or certifications in laboratory/quality/regulatory
Required: Understanding of FDA requirements and Quality Systems
Preferred: Must have good administrative skills (Microsoft Office Suite, LIMS, QMS)
Preferred: 1 – 2 Years in a laboratory environment.
Preferred: 3+ years of GLP/GMP environment in laboratory operations or QA, or combination of both
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.