Quality Assurance Lead – Environmental Monitoring & Facility Validation
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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labeling is accurate. The Eurofins network is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is a market leader in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, and has an emerging global presence in Contract Development and Manufacturing Organisations. Eurofins also has a rapidly developing presence in highly specialised 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 decentralised 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.
Responsibilities
- Draft, revise, and maintain environmental monitoring SOPs, work instructions, forms, and templates for review and approval, following direction from the Vice President, Environmental Monitoring.
- Assist with maintenance of quality documentation associated with laboratory accreditation and scope (e.g., ISO/IEC 17025, A2LA/ANAB), supporting site quality representatives.
- Collaborate with subject‑matter experts for each service line—including cleanroom certification, routine environmental monitoring, EM performance qualification, water testing, compressed gas testing, and microbial identification—to capture technical requirements accurately in procedures and training materials.
- Develop and maintain a working understanding of environmental monitoring equipment across the network (viable air samplers, particle counters, compressed gas and dew point instrumentation) to support quality and documentation requirements.
- Build and maintain environmental monitoring training content, competency assessments, and associated records in coordination with site quality representatives.
- Support data integrity requirements for EM field data capture, review, and reporting, including 21 CFR Part 11 and ALCOA+ principles.
- Assist site quality representatives with environmental monitoring investigations, deviations, out‑of‑limit results, CAPAs, and change controls, providing documentation support and network context.
- Assist with accreditation, audit readiness, regulatory compliance, and data integrity requirements.
- Track quality initiatives, maintain records, and provide recommendations for process improvements.
- Escalate matters requiring direction, resolution, or site leadership engagement to the Vice President, Environmental Monitoring.
- Take ownership of discrete quality‑system workstreams assigned by the Vice President and deliver them to agreed timelines.
- Apply GMP/GLP principles and the highest quality standards in all areas of responsibility.
- Support incorporation of newly added laboratory sites into network EM quality systems as the business grows.
- Conduct all activities safely, efficiently, and in compliance with company policies and applicable regulations.
- Perform other duties as assigned.
Qualifications
- Bachelor’s degree in a scientific or quality‑related field.
- 3+ years of experience in a GMP‑regulated pharmaceutical, biotechnology, medical device, or laboratory environment.
- Experience with quality systems, SOP development, investigations, CAPAs, and training documentation.
- Familiarity with eQMS, LIMS, environmental monitoring, and applicable regulatory requirements.
- Strong organizational, communication, problem‑solving, and project‑management skills.
- Ability to manage multiple priorities, work independently, and travel as needed.
Additional Preferences
- Direct experience with environmental monitoring or cleanroom certification services, in either a contract laboratory or manufacturing setting.
- Familiarity with EU GMP Annex 1, USP, and the ISO 14644 series.
Schedule
Full‑time, Monday‑Friday, 8:00 am – 5:00 pm, with overtime as needed. Approximately 10–25 % travel to network laboratory sites. May require occasional work in controlled environments and off‑shift support. Candidates living within a commutable range of Lancaster, PA are encouraged to apply.
Benefits
- Comprehensive medical coverage, dental, and vision options.
- Life and disability insurance.
- 401(k) with company match.
- Paid vacation and holidays.
- Excellent full‑time benefits package.