Eurofins is seeking an Environmental Monitoring Quality Systems Specialist (GMP/QA) to support the continued growth and standardization of Environmental Monitoring (EM) and Facility Validation (FV) services across our U.S. laboratory network.
This position partners closely with the Vice President, Environmental Monitoring & Facility Validation to develop, implement, maintain, and continuously improve the quality systems that support environmental monitoring operations. The role serves as a key resource for quality documentation, training programs, investigations, compliance initiatives, and accreditation support across multiple laboratory locations.
The ideal candidate combines strong GMP quality systems experience with excellent technical writing, organizational, and document control skills. This is a highly collaborative, systems-focused position that works with site quality representatives, laboratory personnel, and subject matter experts to ensure procedures, training materials, and quality records remain accurate, compliant, and effective.
This is a growth-oriented opportunity for a quality professional looking to expand their impact beyond a single laboratory and contribute to network-wide quality initiatives supporting a rapidly growing business line.
Responsibilities
- Draft, revise, and maintain Standard Operating Procedures (SOPs), work instructions, forms, templates, and quality documents supporting Environmental Monitoring and Facility Validation services.
- Collaborate with subject matter experts and site quality personnel to ensure procedures accurately reflect technical and regulatory requirements.
- Support the administration and maintenance of quality systems, including eQMS, LIMS, training records, controlled documents, and related compliance records.
- Assist with accreditation programs and quality documentation associated with laboratory certifications and standards, including ISO/IEC 17025 requirements.
- Develop and maintain environmental monitoring training materials, competency assessments, and associated documentation across the laboratory network.
- Support environmental monitoring investigations, deviations, out-of-specification or out-of-limit events, CAPAs, and change control activities.
- Assist in maintaining compliance with applicable GMP, GLP, data integrity, and regulatory requirements.
- Support implementation of 21 CFR Part 11 and ALCOA+ principles related to electronic data capture, review, and reporting processes.
- Work with laboratory teams to improve the effectiveness, consistency, and efficiency of environmental monitoring quality systems.
- Participate in internal audits, accreditation audits, regulatory inspections, and audit readiness activities.
- Maintain quality metrics, action item tracking, and project documentation while providing summaries and recommendations to leadership.
- Support the onboarding and integration of newly acquired or newly established laboratory locations into network quality systems.
- Identify opportunities for continuous improvement and assist with implementation of corrective and preventive measures.
- Escalate compliance issues, quality concerns, and risks as appropriate.
- Perform all duties in accordance with company policies, safety requirements, and applicable regulations.
- Perform other related duties as assigned.
Minimum Qualifications
- Bachelor's degree in Biology, Microbiology, Chemistry, Environmental Sciences, Quality Systems, Life Sciences, or a related scientific discipline.
- Minimum of 3 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, contract laboratory, or related regulated environment.
- Experience developing, reviewing, or maintaining SOPs and controlled quality documentation.
- Experience supporting quality systems, investigations, deviations, CAPAs, change controls, or audit programs.
- Familiarity with electronic Quality Management Systems (eQMS), Learning Management Systems (LMS), and/or Laboratory Information Management Systems (LIMS).
- Strong technical writing, document control, and organizational skills.
- Excellent verbal and written communication skills.
- Ability to manage multiple projects and priorities while working independently and collaboratively.
Preferred Qualifications
- Direct experience supporting Environmental Monitoring programs, cleanroom certification, microbiological testing, or facility validation activities.
- Knowledge of ISO/IEC 17025 laboratory requirements.
- Familiarity with EU GMP Annex 1 requirements.
- Understanding of USP <797>, USP <1116>, and ISO 14644 standards.
- Experience supporting laboratory accreditation, regulatory inspections, and audit readiness activities.
- Knowledge of environmental monitoring equipment such as viable air samplers, particle counters, compressed gas testing systems, and related instrumentation.
This is a full-time, first-shift position working Monday through Friday, 8:00 AM to 5:00 PM, with overtime as business needs require.
The position is based in Lancaster, PA and requires approximately 10-25% travel to laboratory locations throughout the network. Occasional work in controlled environments and limited off-shift support may be required.
Candidates living within a commutable distance of Lancaster, PA are encouraged to apply.
What We Offer
- Comprehensive medical, dental, and vision insurance
- Company-paid life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- Career development and advancement opportunities within a global organization
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.