Quality Assurance Lead – Environmental Monitoring & Facility Validation
PharmaBiotechCROMedTechRegulatory AffairsQuality Assurancegmpcrorave
Job description
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. 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.
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