Quality Assurance Specialist

Quality Assurance Specialist

Join a growing Quality Assurance team where you'll play a critical role in maintaining compliance, product quality, and regulatory standards within a pharmaceutical manufacturing environment. This position offers exposure to quality systems, investigations, documentation review, and cross-functional collaboration while supporting continuous improvement initiatives.

Responsibilities

• Review and approve batch records, quality documentation, and raw materials.
• Manage deviations, investigations, CAPAs, and change controls.
• Perform product release and shipping release activities.
• Support Annual Product Reviews and other quality system initiatives.
• Maintain document control and ensure records are audit-ready.
• Utilize electronic quality management systems (eQMS) to manage quality events and workflows.
• Coordinate QA training activities and maintain training records.
• Partner with production, quality, and regulatory teams to ensure compliance with GMP and FDA requirements.

Qualifications

• 2+ years of Quality Assurance experience in a regulated industry (5+ years for higher-level consideration).
• Experience with batch record review, deviations, CAPAs, investigations, and change controls.
• Working knowledge of GMP, FDA, and quality system requirements.
• Strong attention to detail, organization, and documentation skills.
• Experience with electronic quality management systems (eQMS) preferred.
• Bachelor's degree in a scientific discipline preferred.

Why Apply?

• Direct impact on product quality and regulatory compliance.
• Exposure to a broad range of QA systems and processes.
• Collaborative, team-focused environment.
• Opportunity for professional growth and advancement within Quality.
• Stable pharmaceutical environment with long-term career potential.

Work Environment

This is an office-based Quality Assurance role within a regulated pharmaceutical manufacturing environment. You'll work closely with cross-functional teams while helping maintain quality systems, support audits, and ensure products meet the highest standards of compliance and quality.

Job Type & Location

This is a Permanent position based out of Waunakee, WI.

Pay and Benefits

The pay range for this position is $62000.00 - $90000.00/yr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1;
Life and AD&D Insurance, and Short and Long-term Disability;
Health and Flexible Saving Account options;
Employee Assistance Program, generous vacation; paid Holidays; 401k

Workplace Type

This is a fully onsite position in Waunakee,WI.

Final date to receive applications

This position is anticipated to close on Sep 7, 2026.