Environmental Monitoring & Facility Validation Quality Lead

Eurofins USA BioPharma Services; Lancaster (Lancaster County); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Job summary

Eurofins USA BioPharma Services is seeking an experienced quality systems professional to support the Vice President of Environmental Monitoring & Facility Validation. This role develops and maintains quality documents, SOPs, training materials, and 21 CFR Part 11 compliance across the US lab network.

The position focuses on environmental monitoring, validation activities, and regulatory readiness, with travel up to 25% and a path to broader responsibilities as the EM business grows.

Qualifications

• Bachelor's degree in a scientific or quality-related field.
• 3+ years in GMP-regulated pharma, biotech, medical device, or lab settings.
• Experience with quality systems, SOPs, investigations, CAPAs, and training docs.
• Familiarity with eQMS, LIMS, EM, and regulatory requirements.
• Strong organization, communication, problem solving and PM skills.
• Ability to manage multiple priorities and travel as needed.

Responsibilities

• Draft, revise, and maintain EM/FV quality procedures and forms.
• Support ISO/IEC 17025 and site accreditation documentation.
• Collaborate with SMEs to capture service-line requirements in procedures.
• Build training materials, competency records, and related docs.
• Ensure data integrity and 21 CFR Part 11 compliance.
• Assist with investigations, deviations, CAPAs, and change controls.
• Lead network-wide quality system workstreams and timelines.

Skills

GMP experience

Quality systems

SOP development

CAPA investigations

eQMS familiarity

LIMS familiarity

Project management

Travel readiness

Education

Bachelor's degree in scientific or quality field

Tools

eQMS

LIMS

Job description

Eurofins USA BioPharma Services is seeking an experienced quality systems professional to support the Vice President of Environmental Monitoring & Facility Validation. This role develops and maintains quality documents, SOPs, training materials, and 21 CFR Part 11 compliance across the US lab network.

The position focuses on environmental monitoring, validation activities, and regulatory readiness, with travel up to 25% and a path to broader responsibilities as the EM business grows.