Facilities Quality and Compliance Specialist (GMP Lab)

Position

Facilities Quality and Compliance Specialist

Location

Middleton, Wisconsin

Department

Facilities

This is a fully onsite role based at our GMP Lab in Middleton, Wisconsin. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.

Position Summary

The Facilities Quality and Compliance Specialist ensures that facilities and maintenance activities are planned, executed, and documented in a state of control and in compliance with 21 CFR, GMP requirements, and internal quality systems. The position partners closely with Facilities, Maintenance, Engineering, Quality, and EHS teams and supports audit readiness, change management, and lifecycle compliance of facility systems.

Role Responsibilities:

• Partner with Facilities and Maintenance teams to ensure compliant use of CMMS / CAFM systems, accurate recordkeeping, and effective lifecycle documentation.
• Author, manage, and assess Change Controls related to facilities, utilities, and infrastructure, including completion of risk assessments, and impact evaluations.
• Ensure appropriate risk assessments and impact evaluations are completed and documented.
• Understand CC workflows, approval requirements, and downstream impacts.
• Support deviation investigations, CAPA development, and effectiveness checks related to facilities compliance issues.
• Support internal and external audits and regulatory inspections, including resolution of QA audit findings, inspection responses, remediation plans, and follow-up actions.
• Support drawing validation and documentation traceability related to facility systems.
• Provide compliance guidance for facilities-related commissioning, qualification, and validation activities as needed, including review of CQV documentation and drawing validation to ensure traceability and risk-based lifecycle compliance.
• Partner with Procurement to support maintenance contracts, including development of task lists and adherence to contract requirements and KPIs.
• Ensure all work is performed in a timely, professional manner and in compliance with OSHA, EHS, and organizational policies, maintaining required training and readiness.
• Daily operational support and other duties as needed or assigned.

Key Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills, and Abilities:

• Proven ability to handle multiple tasks simultaneously and balance priorities
• Strong problem-solving skills
• Strong computer skills in Microsoft Office Suite
• Effective oral and written communication skills
• Basic understanding of building systems (mechanical, electrical, security, etc.)
• Knowledge of electrical, plumbing, mechanical and/or light general construction may be required
• Ability to effectively interact with outside vendors and internal customers
• Positive attitude and ability to work well with others
• Comfort with ambiguity and effectiveness during periods of uncertainty and change
• May require knowledge and understanding of computerized maintenance and work order systems
• May require a strong understanding of security systems

Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to move effectively throughout facility, including lifting and moving objects up to 35-50 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.