Environmental Monitoring Quality Systems Specialist

Eurofins; Lancaster (Lancaster County); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services is seeking a Quality Systems professional to build out and maintain GMP/GLP quality systems supporting environmental monitoring and facility validation across the US laboratory network. You will draft and revise SOPs, training materials, forms and templates, track CAPAs and deviations, ensure data integrity (21 CFR Part 11) and prepare clear summaries for leadership review.

This growth role requires a BS in a scientific or quality field and 3+ years in a

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.

Responsibilities

• Draft, revise, and maintain environmental monitoring SOPs, work instructions, forms, and templates for review and approval, working to direction set by the Vice President, Environmental Monitoring.
• Assist with maintenance of quality documentation associated with laboratory accreditation and scope (e.g., ISO/IEC 17025, A2LA / ANAB), in support of site quality representatives.
• Work with designated 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 the environmental monitoring equipment in use across the network, including but not limited to viable air samplers, particle counters, and compressed gas and dew point instrumentation; sufficient to support the quality and documentation requirements associated with their use.
• 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.

Skills

Quality systems

SOP development

CAPA management

Training documentation

Regulatory compliance

Education

Bachelor's degree in science/quality field

Tools

eQMS

LIMS

Environmental monitoring familiarity

Job description

Eurofins USA BioPharma Services is seeking a Quality Systems professional to build out and maintain GMP/GLP quality systems supporting environmental monitoring and facility validation across the US laboratory network. You will draft and revise SOPs, training materials, forms and templates, track CAPAs and deviations, ensure data integrity (21 CFR Part 11) and prepare clear summaries for leadership review.

This growth role requires a BS in a scientific or quality field and 3+ years in a