Quality Assurance Assistant - Environmental Monitoring & Facility Validation

About the role

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.

Qualifications & Requirements

• 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.

Additional Information

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