Quality Assurance Lead (Environmental Monitoring & Facility Validation)

Location: Lancaster, PA, USA; candidates within a commutable range are encouraged to apply. The role involves approximately 10–25% travel to network laboratory sites, occasional work in controlled environments, and off-shift support.

Company

hirify.global is an international life sciences company providing analytical testing, laboratory, pharmaceutical, environmental, and related scientific services.

What you will do

• 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 across the laboratory network.
• Support investigations, deviations, CAPAs, change controls, and corrective action implementation.
• Assist with accreditation, audit readiness, regulatory compliance, and data integrity activities.
• Track quality initiatives, maintain records, recommend process improvements, and support onboarding of new laboratory sites.

Requirements

• Bachelor’s degree in a scientific or quality-related field.
• At least 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, with the ability to manage priorities and work independently.
• Ability to travel as needed and provide occasional off-shift support.

Culture & Benefits

• Full-time Monday–Friday schedule, generally 8:00 a.m.–5:00 p.m., with overtime as needed.
• Medical, dental, and vision coverage.
• Life and disability insurance.
• 401(k) plan with company match.
• Paid vacation and holidays.