Quality Assurance Specialist II - Internal Quality

The Position

The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead.  Key functions of this position may involve review of manufacturing batch records, analytical data and reports, associated documents and other activities needed to support operations within the Quality Assurance department and will also support general quality systems related to current Good Manufacturing Practices (cGMP) within the organization. The Specialist II is expected to interact with multiple internal departments.

Responsibilities

• Interact with representatives from other departments, including manufacturing, QC, and Analytical Development, to obtain the necessary information for review of documentation.
• 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.
• Organization and control of project related documentation.
• Issue, review, and reconcile controlled forms.
• Review, verify, and reconcile labels.
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/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.
• Additional duties as assigned.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• Minimum of 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 consistently communicate with external parties in a professional manner.
• Ability to follow company procedures, work instructions, and policies.
• Excellent attention to detail and organizational skills.
• Ability to work independently with minimal supervision as well as manage priorities within a fast-paced environment.

Preferred

• Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15).
• Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.
• Prior experience with use of an electronic document management system in a regulated environment