Quality Assurance Specialist II - Internal Quality
About The Position
The Quality Assurance Specialist II supports ongoing preclinical, clinical, and commercial drug development programs within Arrowhead’s Quality Assurance department. The role reviews manufacturing batch records, analytical data and reports, associated documentation, and other materials needed to support operations. It also supports quality systems related to current Good Manufacturing Practices (cGMP) and interacts with multiple internal departments. The position includes reviewing and approving analytical data, manufacturing documentation, and raw material records; performing raw-material lot disposition and release; supporting room releases and on-floor QA; assisting with investigations and deviations; and maintaining controlled and project-related documentation. The Specialist II is expected to perform many reviews and approvals with minimal supervision, maintain knowledge of applicable compliance expectations, and support documentation-practice, GMP, and data-integrity training as needed.
Requirements
- Bachelor of Science or Bachelor of Arts degree in an applicable scientific field, such as chemistry, biology, or biochemistry.
- At least 3 years of quality assurance or similar experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization.
- Working knowledge of GMP, GCP, and/or GLP regulations, as well as ICH and FDA guidance documents.
- Excellent interpersonal, verbal, and written communication skills.
- 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.
- Current, valid authorization to work in the country where the role is located.
Nice To Haves
- Experience with quality systems supporting GMP regulations, including 21 CFR Parts 11, 210, and 211, and EU GMP, including Annex 11 and 15.
- Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.
- Prior experience using an electronic document management system in a regulated environment.
Responsibilities
- Work with representatives from manufacturing, QC, Analytical Development, and other departments to obtain information needed for documentation review.
- Review and approve analytical testing data and final reports from internal and external sources with minimal supervision.
- Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
- Review and approve internally generated raw-material data and documentation with minimal supervision.
- Perform lot disposition and release of raw materials with minimal supervision.
- Perform room releases as required.
- Perform QA on the floor as required.
- Assist with investigations and deviations as appropriate with minimal supervision.
- Organize and control project-related documentation.
- Issue, review, and reconcile controlled forms.
- Review, verify, and reconcile labels.
- Scan and upload executed documents to the EDMS, categorize them appropriately, and route them for verification or approval.
- Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
- Assist with Good Documentation Practices, GMP, and data-integrity training as needed.
- Perform additional duties as assigned.
Benefits
- Competitive salaries
- Excellent benefit package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
