QA Lead, Environmental Monitoring & Facility Validation

Eurofins USA BioPharma Services; Lancaster (Lancaster County); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services invites a Quality Assurance Lead for Environmental Monitoring & Facility Validation to drive EM quality systems across our US laboratory network. You will draft SOPs, train staff, and maintain documentation in line with GMP/GLP expectations.

You will collaborate with SME teams, ensure data integrity per 21 CFR Part 11, and support accreditation activities while advancing EM and FV programs. Occasional travel to network sites is expected.

Qualifications

• Bachelor’s degree in a scientific or quality-related field.
• Experience with GMP/GLP regulated environments and quality systems.
• Proven ability to develop SOPs, investigate CAPAs, and manage training documentation.

Responsibilities

• Draft, revise, and maintain EM SOPs, work instructions, and forms with VP guidance.
• Assist with accreditation and regulatory documentation (ISO/IEC 17025, A2LA/ANAB).
• Collaborate with SMEs across service lines to capture requirements in procedures and training.
• Develop understanding of EM equipment across the network and support documentation.
• Support data integrity and 21 CFR Part 11 compliance in EM data capture and reporting.
• Assist with investigations, deviations, CAPAs, and change controls.

Skills

GMP/GLP knowledge

Quality systems

SOP development

CAPA investigations

Training documentation

eQMS

LIMS

Environmental monitoring

Communication

Project management

Willing to travel

Education

Bachelor's degree in a scientific or quality-related field

Tools

LIMS

eQMS

Job description

Eurofins USA BioPharma Services invites a Quality Assurance Lead for Environmental Monitoring & Facility Validation to drive EM quality systems across our US laboratory network. You will draft SOPs, train staff, and maintain documentation in line with GMP/GLP expectations.

You will collaborate with SME teams, ensure data integrity per 21 CFR Part 11, and support accreditation activities while advancing EM and FV programs. Occasional travel to network sites is expected.