Quality Assurance Specialist II - Internal Quality

Responsibilities

• Interact with manufacturing, QC, and Analytical Development to gather documentation for review.
• Review and approve analytical testing data and final reports (internal/external) with minimal supervision.
• Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
• Review and approve internally generated raw material data/documentation with minimal supervision.
• Perform lot disposition/release of raw materials; perform room releases and QA on the floor as required.
• Assist with investigations and deviations; organize and control project documentation.
• Issue, review, and reconcile controlled forms; review/verify/reconcile labels.
• Scan/upload executed documents to EDMS, categorize, and route for verification/approval.
• Maintain knowledge of drug development compliance; assist with GDoc practices, GMP, and data integrity training.
• Additional duties as assigned.

• BS/BA in chemistry, biology, biochemistry (or applicable scientific field).
• 3+ years QA or similar experience in biotech/pharma development, manufacturing, or contract manufacturing.
• Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance.
• Strong interpersonal, verbal, and written communication; professional external communications.
• Follow procedures and policies; attention to detail; organizational skills.
• Ability to work independently with minimal supervision and manage priorities in a fast-paced environment.

• Quality systems experience supporting GMP regulations (21 CFR Parts 11, 210, 211; EU GMP incl. Annex 11 & 15).
• Microsoft Word/Excel/Smartsheet; EDMS experience in regulated environments.

• Wisconsin pay range: $70,.
• Competitive salaries and an excellent benefit package.

• Must have current, valid authorization to work in the country where the role is located.