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 authoritySupports admininistration function by:Acting as the Deputy QAS/QAM in their absenceMonitoring quality systems deadlines and reports to management pending and overdue activitiesAssisting with the PO system for the QA group o maintaining Analytical Subcontractor complianceWriting, reviewing, and approving Events, CAPA, OOS/OOT and Change ControlManaging investigationsWriting, reviewing, and conducting Quality System, cGMP, and GLP trainingParticipating in data analysis and reportingServing as QA trainer, as neededSupporting sister sites(s) as requiredSupports all Quality Assurance I and II roles for:AuditingData reportingDocument controlEquipment controlManufacturing (as required)Stability (as required)Supports Auditing by:Performing Internal audits per Standard Operating ProcedureSupporting and hosting client and regulatory auditsConducting external auditsSupports Regulatory ComplianceSupports the Stability Program as needed by:Reviewing and approving Stability ProtocolsReviewing Stability Chamber Pull SchedulesReviewing and approving Stability Chamber mapping o monitoring and following up Stability Chamber excursions o other task as requiredSupports Manufacturing as needed by:Executing and reviewing batch recordsQuality assurance inspection and release of cGMP materials o reviewing, creating, and approving Batch RecordsReviewing, creating, and approving Certificates of ComplianceConducting cGMP vendor qualificationOther functions as assigned

Qualifications

Basic Minimum Qualifications: 

10+ years in a GMP/GLP environment with 7+ years in a QA roleOr 5 years of similar experience plus a Bachelor's Degree in a scientific fieldMinimum of an Associate’s DegreeUnderstanding of FDA requirements and Quality SystemsMust have good administrative skills (Microsoft Office Suite, LIMS, QMS)Ability to work in the US, for any company, indefinitely, without sponsorship

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 optionsLife and disability insurance401(k) with company matchPaid vacation and holidays

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