Quality Assurance Specialist

QA Specialist

The Quality Systems Specialist supports cGMP quality system activities within a biopharmaceutical manufacturing environment, executing and maintaining processes managed through the Master Control electronic Quality Management System (eQMS). This role involves building and managing a supplier and vendor quality program, including qualification and auditing of suppliers, with occasional domestic and international travel required. The specialist is responsible for GMP training programs, validation and qualification document review, deviations, investigations, CAPAs, and change controls.

Collaboration cross-functionally to ensure compliance with internal procedures and global regulatory requirements is essential.

Responsibilities:

• Build and manage a supplier and vendor quality program, including qualification and auditing of suppliers.
• Execute and maintain processes managed through the Master Control eQMS.
• Conduct GMP training programs, validation and qualification document reviews.
• Handle deviations, investigations, CAPAs, and change controls.
• Collaborate cross-functionally to ensure compliance with internal procedures and global regulatory requirements.
• Support continuous improvement initiatives.
• Coordinate internal and external audits.
• Manage training documentation and oversee change control governance.
• Support Annual Product Review (APR) preparation.

Additional Skills &

Qualifications:

• Bachelor's degree or above in a Scientific discipline
• 1+ years of quality experience in the biopharma/pharmaceutical industry preferred
• Experience in managing vendors and auditing

Work Environment:

The position operates on a 1st shift schedule from Monday to Friday, starting between 7-9am for 8-hour workdays. This position operates in an office based environment.

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. 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 Jul 31, 2026.