Quality Assurance Lead – Environmental Monitoring & Facility Validation

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. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing, agroscience Contract Research Organisation services, genomics, discovery pharmacology, forensics, advanced material sciences, clinical study support, and emerging Contract Development and Manufacturing Organisations. With over 58,000 staff in 900 laboratories across more than 54 countries, Eurofins offers a portfolio of over 200,000 analytical methods.

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 within 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 <797> / <1116>, and the ISO 14644 series.

Additional Information

• Full‑time position, 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.
• Responsibilities may be adjusted based on business needs.

Benefits

• Comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.