Facilities Quality and Compliance Specialist (GMP Lab)

Thermo Fisher Scientific•Middleton, WI

3d•Onsite

About The Position

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.

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.
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
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.

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.