Environmental Monitoring Quality Systems Specialist (GMP/QA)

Eurofins•Lancaster, PA

21h•Onsite

About The Position

Eurofins is seeking an Environmental Monitoring Quality Systems Specialist to support the growth and standardization of Environmental Monitoring (EM) and Facility Validation (FV) services across its U.S. laboratory network. The position partners closely with the Vice President, Environmental Monitoring & Facility Validation to develop, implement, maintain, and continuously improve quality systems for environmental monitoring operations. It supports quality documentation, training programs, investigations, compliance initiatives, and accreditation across multiple laboratory locations. The role works collaboratively with site quality representatives, laboratory personnel, and subject matter experts to keep procedures, training materials, and quality records accurate, compliant, and effective. It is a network-wide opportunity for a quality professional with GMP quality systems experience, technical writing, organizational, and document control skills. The position is based in Lancaster, Pennsylvania, with approximately 10–25% travel to laboratories across the network. Occasional work in controlled environments and limited off-shift support may be required.

Requirements

Bachelor's degree in Biology, Microbiology, Chemistry, Environmental Sciences, Quality Systems, Life Sciences, or a related scientific discipline.
At least 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.

Nice To Haves

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.

Responsibilities

Draft, revise, and maintain SOPs, work instructions, forms, templates, and other quality documents supporting Environmental Monitoring and Facility Validation services.
Collaborate with subject matter experts and site quality personnel to ensure procedures reflect technical and regulatory requirements.
Support 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 related 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 for 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, and provide summaries and recommendations to leadership.
Support onboarding and integration of newly acquired or newly established laboratory locations into network quality systems.
Identify continuous-improvement opportunities and assist with corrective and preventive measures.
Escalate compliance issues, quality concerns, and risks as appropriate.
Perform duties in accordance with company policies, safety requirements, and applicable regulations.
Perform other related duties as assigned.