Quality Systems Associate - Environmental Monitoring

Eurofins BioPharma Product Testing North America; Lancaster (Lancaster County); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services is seeking a seasoned Quality Systems professional to lead environmental monitoring and facility validation quality programs across the US laboratory network. This growth role involves drafting procedures, maintaining accreditation-related docs, and coordinating with service-line SMEs to capture technical requirements.

You will support data integrity, CAPAs, and change controls, driving compliance with 21 CFR Part 11 and ALCOA+ while preparing networks for audits.

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.
• Direct experience with environmental monitoring or cleanroom certification services is a plus.
• Familiarity with EU GMP Annex 1, USP <797> / <1116>, and the ISO 14644 series is a plus.

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.
• 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, Environmental Monitoring, and deliver them to agreed timelines.
• Apply GMP/GLP principles and the highest quality standards in all areas of responsibility.
• Support the incorporation of newly added laboratory sites into network EM quality systems as the business grows.
• Conduct all activities in a safe and efficient manner, and in compliance with company policies and applicable regulations.
• Perform other duties as assigned.

Skills

Quality Systems

GMP/GLP Knowledge

eQMS/LIMS familiarity

Project Management

Communication

Travel readiness

Education

Bachelor's degree in scientific or quality-related field

Tools

eQMS

LIMS

GxP compliance tools

Job description

Eurofins USA BioPharma Services is seeking a seasoned Quality Systems professional to lead environmental monitoring and facility validation quality programs across the US laboratory network. This growth role involves drafting procedures, maintaining accreditation-related docs, and coordinating with service-line SMEs to capture technical requirements.

You will support data integrity, CAPAs, and change controls, driving compliance with 21 CFR Part 11 and ALCOA+ while preparing networks for audits.