QA Auditor I

About the role

Hybrid QA Auditor I position based at the GMP Laboratory in Middleton, WI; flexible hybrid work location within the US; full‑time, first shift Monday‑Friday. Relocation assistance is not provided; candidates must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check including drug screening.

Responsibilities

• 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.

Requirements

Bachelor's degree or equivalent; associate's degree with relevant experience is acceptable in lieu of a bachelor's degree. Prior laboratory or QA experience providing the knowledge, skills, and abilities to perform the job (comparable to 1 year). Equivalency of appropriate education, training, and/or directly related experience may be considered.

Qualifications

• 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

Work 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.

Schedule

Work schedule: standard Monday‑Friday; full‑time, first shift.