QA Auditor I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Laboratory Setting, Office

Job Description

This is a hybrid role based at our GMP Laboratory in Middleton, WI. 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.

Location: Flexible Hybrid; Middleton, WI

Available Shift: Full-Time; 1st Shift, Monday - Friday

Join our Quality Assurance team as a QA Auditor I and play an important role in ensuring the quality, integrity, and timely release of GMP laboratory project data. In this role, you will perform routine quality assurance audits and inspections, support GMP compliance, and partner with laboratory teams to ensure project data and associated documentation meet applicable regulatory, procedural, and quality requirements.

What You'll Do

• Conduct routine QA audits of GMP laboratory project data and associated documentation to support accurate and timely project data release.
• Review project data and documentation for compliance with applicable GMP requirements, approved procedures, protocols, and other governing documents.
• Document audit observations and communicate findings clearly and accurately to laboratory personnel and appropriate stakeholders.
• Work collaboratively with laboratory teams to facilitate timely resolution of audit observations and completion of QA review activities.
• Perform routine facility inspections to assess compliance with GMP requirements, established procedures, and quality standards.
• Assist with or perform other quality assurance activities, including documentation reviews, quality assessments, and process-related reviews.
• Serve as a QA resource to laboratory and operational teams regarding routine GMP, audit, and quality requirements.
• Support quality and process improvement initiatives that enhance compliance, data integrity, audit effectiveness, and operational efficiency.
• Maintain accurate, complete, and timely documentation of assigned QA activities in accordance with established procedures.
• Manage assigned audit activities and priorities to support project schedules and laboratory data release timelines.

Education and Experience

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree
• Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 year).

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

• Introductory knowledge of applicable GMP requirements and relevant regulatory expectations.
• Working knowledge of standard operating procedures (SOPs), work practice documents (WPDs), and controlled documentation.
• Strong attention to detail with a focus on data accuracy, completeness, and integrity.
• Effective written and verbal communication skills, including appropriate use of scientific and technical terminology.
• Ability to review laboratory data and documentation against established requirements and identify potential discrepancies or compliance concerns.
• Good analytical and problem-solving skills.
• Strong organizational and time-management skills with the ability to prioritize multiple assignments and meet established timelines.
• Ability to work effectively both independently and as part of a cross-functional team.
• Ability to clearly document and communicate audit observations.
• Demonstrated flexibility and adaptability in a changing operational environment.
• Basic computer proficiency with the ability to learn and effectively use applicable quality and business systems.

Working Conditions and Environment

• Work is performed primarily in office and GMP laboratory environments.
• May involve entry into laboratory areas where chemical, biological, or other materials are handled.
• Routine use of computers and other office equipment.
• Personal protective equipment, including protective eyewear, laboratory garments, and gloves, may be required based on the work activity and laboratory environment.

Physical Requirements

• Ability to remain in a stationary or upright position for extended periods, typically 6-8 hours per day.
• Ability to perform repetitive hand and finger movements associated with computer and documentation activities.
• Frequent mobility within office and laboratory environments.
• Occasional crouching, stooping, bending, and twisting.
• Ability to lift, carry, or otherwise move work-related items weighing approximately 15-20 pounds.
• Ability to access and effectively use internally developed and commercially available computer applications.
• Ability to communicate and exchange information effectively with individuals and diverse groups.
• Ability to manage multiple priorities and perform effectively in an environment with changing demands and timelines.
• Regular and consistent attendance is required.

Why Join Us?

At Thermo Fisher Scientific, you'll be part of a global team committed to quality and scientific excellence. Your work in GMP Quality Assurance will directly support the integrity and timely release of laboratory project data while helping ensure our operations consistently meet applicable regulatory and quality requirements.

Join us and help ensure quality, compliance, and data integrity are built into every project we deliver.