Quality Assurance Specialist II - External Quality

Responsibilities:

• - Interact with personnel company wide to obtain information needed for quality assurance support of development, clinical, and commercial programs.
• - Review and approve vendor generated documentation, including executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports.
• - Collaborate with vendors on quality events and non-conformances per applicable quality agreements.
• - Perform lot disposition and generate certificates of compliance (CoC) as necessary.
• - Assist with preparation, update, review, and routing of Arrowhead procedural documents.
• - Scan and upload executed documents to the EDMS, categorize properly, and route for verification/approval.
• - Assist with QA duties as needed.

• - BS/BA in an applicable scientific field (e.g., chemistry, biology, biochemistry).
• - Minimum 3 years of quality assurance or similar experience in biotech/pharmaceutical development, manufacturing, or contract manufacturing.
• - Working knowledge of GMP, GCP, and/or GLP; ICH and FDA guidance documents.
• - Excellent interpersonal, verbal, and written communication.
• - Ability to communicate professionally with external parties.
• - Ability to follow company procedures, work instructions, and policies.
• - Excellent attention to detail and organizational skills.
• - Ability to work independently with minimal supervision and manage priorities in a fast-paced environment.

• - Prior experience using an electronic document management system (regulated environment).
• - Proficient with Adobe Acrobat, Microsoft Office, and Smartsheet.

• - Wisconsin pay range: $70,000 USD - $85,000 USD.
• - Competitive salaries and an excellent benefit package.