Quality Assurance Specialist 3 - Early Phase Quality Operations

The Position

The purpose of this position is to provide quality assurance support to early phase clinical programs focusing on those utilizing contract development, manufacturing, and testing organizations. The incumbent will review vendor documentation and perform lot disposition for investigational product per applicable quality agreements and phase-appropriate GMP requirements, as well as capture quality data and generate metrics for vendors. The incumbent will be expected to interact with internal departments as well as multiple contract organizations, including contract manufacturers, contract testing laboratories, clinical packaging and labeling providers, and clinical supply depots, to support ongoing early phase clinical programs, from first-in-human through Phase 2, at Arrowhead Pharmaceuticals, Inc.

Responsibilities

• Interact with personnel companywide to obtain the necessary information and details to provide quality assurance support of early phase clinical programs.
• Serve as a day-to-day Quality Assurance contact for contract manufacturers (CDMOs/CMOs), contract testing laboratories, clinical packaging and labeling providers, and clinical supply depots supporting early phase programs.
• Review and approve vendor generated documentation for early phase clinical material, including but not limited to, master and executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports, against approved specifications and the applicable IND/CTA/IMPD.
• Review clinical label text and labeling records from packaging and labeling vendors, including label reconciliation and verification of required regional content.
• Perform lot disposition of investigational product per the applicable quality agreement and generate certificates of compliance (CoC) as necessary.
• Assemble and review documentation packages supporting Qualified Person (QP) release of product supplied to studies outside the US, as assigned.
• Collaborate with vendors on quality events and non-conformances as outlined in the applicable quality agreement, including review of vendor deviations, OOS/OOT results, and investigations, and track events to timely closure.
• Review vendor change notifications and support Arrowhead assessment of their impact on investigational product.
• Review vendor stability protocols, reports, and data supporting early phase material, as assigned.
• Support evaluation of shipping and storage temperature excursions affecting investigational product held at vendors, clinical supply depots, and clinical sites.
• Support vendor qualification activities, including quality questionnaires, audit scheduling and logistics, audit response tracking, and maintenance of quality agreement records, as necessary and assigned.
• Support technical transfer to vendors through review of transfer related documentation, as assigned.
• Assist with tracking vendor quality metrics, including batch record review cycle time, quality event aging, and right-first-time performance; notify QA management of any performance issues.
• Assist with preparation, update, review, and routing of Arrowhead procedural documents, as necessary.
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
• Draft, review, and approve standard operating procedures (SOP) and work instructions (WI) as needed.
• Maintain knowledge of current compliance expectations and regulations pertaining to early phase drug development and investigational product supply (e.g., 21 CFR Parts 210/211, FDA cGMP guidance for Phase 1 investigational drugs, ICH Q7, and EU GMP Annex 13).
• Assist with QA duties as needed.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• Minimum of 5 years of quality assurance or similar experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization, including experience supporting early phase clinical programs.
• Working knowledge of GMP, GCP, and/or GDP regulations as well as ICH and FDA guidance documents, including phase-appropriate application of GMP to investigational products.
• Experience reviewing batch records, certificates of analysis, and testing records generated by external manufacturers and laboratories.
• 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.
• Ability to travel occasionally, up to 10%, to support vendor oversight, as needed.

Preferred

• Prior experience with use of an electronic document management system in a regulated environment is preferred
• Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, and SmartSheet.
• Experience supporting IND/CTA/IMPD enabling programs and first-in-human study starts.
• Experience supporting QP release or clinical trial supply to studies outside the US.
• Experience with oligonucleotide, peptide, or biologic modalities and/or sterile drug product.
• Experience with quality agreements and vendor quality metrics programs.

Wisconsin pay range 78000 - 98000 USD