Senior Quality Assurance Specialist - External Quality
Arrowhead Pharmaceuticals
7 hours ago
Remote friendly (Madison, WI)
United States
Operations
The purpose of this position is to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations. The incumbent will review vendor documentation, perform lot disposition per applicable quality agreements, capture quality data, and generate metrics for vendors. Expected to interact with internal departments and contract organizations to support ongoing pre-clinical and clinical development programs.
Responsibilities:
- Interact with personnel companywide to obtain information needed to provide QA support of development, clinical, and commercial programs.
- Review and approve vendor documentation (master/executed batch records, testing records, CoAs, labels, protocols, reports).
- Perform lot disposition and generate certificates of compliance (CoC) as necessary.
- Collaborate with vendors on quality events and non-conformances.
- Review and release completed manufacturing batch documentation, including QC data and issuance of CoAs.
- Organize and control quality, compliance, and project documentation.
- Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
- Provide QA support for other departments (QC, Project Management, Toxicology, Clinical Operations, Supply Chain, etc.).
- Participate in meetings with vendors/external organizations as the QA team representative.
- Assist with tracking vendor quality metrics; notify QA management of performance issues.
- Prepare/update/review/route Arrowhead procedural documents.
- Draft/review/approve SOPs and work instructions (WIs) as needed.
Requirements:
- 8+ years QA or similar experience in pharmaceutical development and/or contract manufacturing.
- BS/BA in chemistry, biology, biochemistry, or similar.
- Working knowledge of drug GMP regulations and ICH/FDA guidance.
- Excellent written and verbal communication skills.
- Team player; ability to work independently with minimal supervision; manage priorities in a fast-paced environment.
- Detail-oriented self-starter who anticipates and resolves problems.
Preferred:
- Experience with quality systems for drug-device combination products (21 CFR Part 3) and medical devices QSR (21 CFR Part 820/ISO 13485).
- Proficiency with Adobe Acrobat, Microsoft Office, and SmartSheet.
Benefits/Compensation:
- Wisconsin pay range: $90,000–$110,000 USD.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.
Responsibilities:
- Interact with personnel companywide to obtain information needed to provide QA support of development, clinical, and commercial programs.
- Review and approve vendor documentation (master/executed batch records, testing records, CoAs, labels, protocols, reports).
- Perform lot disposition and generate certificates of compliance (CoC) as necessary.
- Collaborate with vendors on quality events and non-conformances.
- Review and release completed manufacturing batch documentation, including QC data and issuance of CoAs.
- Organize and control quality, compliance, and project documentation.
- Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
- Provide QA support for other departments (QC, Project Management, Toxicology, Clinical Operations, Supply Chain, etc.).
- Participate in meetings with vendors/external organizations as the QA team representative.
- Assist with tracking vendor quality metrics; notify QA management of performance issues.
- Prepare/update/review/route Arrowhead procedural documents.
- Draft/review/approve SOPs and work instructions (WIs) as needed.
Requirements:
- 8+ years QA or similar experience in pharmaceutical development and/or contract manufacturing.
- BS/BA in chemistry, biology, biochemistry, or similar.
- Working knowledge of drug GMP regulations and ICH/FDA guidance.
- Excellent written and verbal communication skills.
- Team player; ability to work independently with minimal supervision; manage priorities in a fast-paced environment.
- Detail-oriented self-starter who anticipates and resolves problems.
Preferred:
- Experience with quality systems for drug-device combination products (21 CFR Part 3) and medical devices QSR (21 CFR Part 820/ISO 13485).
- Proficiency with Adobe Acrobat, Microsoft Office, and SmartSheet.
Benefits/Compensation:
- Wisconsin pay range: $90,000–$110,000 USD.
Application instruction:
- Candidates must have current, valid authorization to work in the country where this role is located.