Quality Assurance Lead – Environmental Monitoring & Facility Validation

Eurofins USA BioPharma Services; Lancaster (Lancaster County); Vor Ort; USD 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company match

Paid vacation and holidays

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

GMP/GLP knowledge

Quality systems

SOP development

CAPA investigations

Training documentation

eQMS

LIMS

Environmental monitoring

Communication

Project management

Willing to travel

Ausbildung

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

Tools

LIMS

eQMS

Jobbeschreibung

Quality Assurance Lead – Environmental Monitoring & Facility Validation

• Full-time

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.

Supporting the Vice President, Environmental Monitoring & Facility Validation in building out and maintaining the quality systems that underpin environmental monitoring (EM) and facility validation (FV) services across the US laboratory network. The position provides quality systems and documentation support across the network.

The role is systems-facing. It gathers input from the quality systems (e-LIMS/eQMS), site quality representatives and from subject matter experts for each service line, drafts and maintains procedures, training materials, checklists, and quality documentation for review and approval, tracks actions through to closure, and prepares clear summaries and recommendations for the Vice President's consideration.

This is a growth position. It is intended for an experienced quality systems professional who is ready to take on network-wide scope for the first time, and it is structured to expand in responsibility as the environmental monitoring business line grows.

Responsibilities

• Draft, revise, and maintain environmental monitoring SOPs, work instructions, forms, and templates for review and approval, working to direction set by the Vice President, Environmental Monitoring.
• Assist with maintenance of quality documentation associated with laboratory accreditation and scope (e.g., ISO/IEC 17025, A2LA / ANAB), in support of site quality representatives.
• Work with designated subject matter experts for each service line, including cleanroom certification, routine environmental monitoring, EM performance qualification, water testing, compressed gas testing, and microbial identification, to capture technical requirements accurately in procedures and training materials.
• Develop and maintain a working understanding of the environmental monitoring equipment in use across the network, including but not limited to viable air samplers, particle counters, and compressed gas and dew point instrumentation; sufficient to support the quality and documentation requirements associated with their use.
• Build and maintain environmental monitoring training content, competency assessments, and associated records in coordination with site quality representatives.
• Support data integrity requirements for EM field data capture, review, and reporting, including 21 CFR Part 11 and ALCOA+ principles.
• Assist site quality representatives with environmental monitoring investigations, deviations, out-of-limit results, CAPAs, and change controls, providing documentation support and network context.
• Assist with accreditation, audit readiness, regulatory compliance, and data integrity requirements.
• Track quality initiatives, maintain records, and provide recommendations for process improvements.
• Escalate matters requiring direction, resolution, or site leadership engagement to the Vice President, Environmental Monitoring.
• Take ownership of discrete quality system workstreams assigned by the Vice President, Environmental Monitoring, and deliver them to agreed timelines.
• Apply GMP/GLP principles and the highest quality standards in all areas of responsibility.
• Support the incorporation of newly added laboratory sites into network EM quality systems as the business grows.
• Conduct all activities in a safe and efficient manner, and in compliance with company policies and applicable regulations.
• Perform other duties 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.

Additional Preferences

• Direct experience with environmental monitoring or cleanroom certification services, in either a contract laboratory or manufacturing setting.
• Familiarity with EU GMP Annex 1, USP <797> / <1116>, and the ISO 14644 series.

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.