Quality Assurance Lead – Environmental Monitoring & Facility Validation

The Quality Assurance Lead supports quality systems, documentation, training, and compliance activities for Environmental Monitoring and Facility Validation services across the US laboratory network. This role works closely with site quality teams and technical experts to drive consistency, support quality initiatives, and promote continuous improvement.

Responsibilities

• Develop, maintain, and coordinate SOPs, work instructions, forms, training materials, and other quality documentation.
• Partner with site quality representatives and subject matter experts to standardize processes and support quality systems across the network.
• Support investigations, deviations, CAPAs, change controls, and implementation of corrective actions.
• Assist with accreditation, audit readiness, regulatory compliance, and data integrity requirements.
• Track quality initiatives, maintain records, and provide recommendations for process improvements.
• Support onboarding of new laboratory sites and other quality-related projects as assigned.

• 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.

The position is full-time, Monday-Friday, 8:00am-5:00pm, with overtime as needed. There is an expectation of approximately 10–25% travel to network laboratory sites. This position may require occasional work in controlled environments and off-shift support. Responsibilities may be adjusted based on business needs. Candidates living within a commutable range of Lancaster, PA are encouraged to apply.

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.