QA Specialist III, Early Phase Quality Operations

Arrowhead Pharmaceuticals•Verona, WI

6d•$78,000 - $98,000

About The Position

The QA Specialist III provides quality assurance support for early phase clinical programs, particularly programs using contract development, manufacturing, and testing organizations. The role reviews vendor documentation and performs investigational product lot disposition in accordance with quality agreements and phase-appropriate GMP requirements, while capturing quality data and generating vendor metrics. The position supports programs from first-in-human through Phase 2 and works with internal departments and contract manufacturers, testing laboratories, clinical packaging and labeling providers, and clinical supply depots.

Requirements

Bachelor’s degree in an applicable scientific field such as chemistry, biology, or biochemistry.
At least 5 years of quality assurance or similar experience in biotech or pharmaceutical development, manufacturing, or a contract manufacturing organization, including support for early phase clinical programs.
Working knowledge of GMP, GCP, and/or GDP regulations and ICH and FDA guidance, 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 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.
Ability to travel occasionally, up to 10%, to support vendor oversight as needed.
Current, valid authorization to work in the country where the role is located.

Nice To Haves

Experience using an electronic document management system in a regulated environment.
Competence with Adobe Acrobat, Microsoft Office programs, and SmartSheet.
Experience supporting IND/CTA/IMPD-enabling programs and first-in-human study starts.
Experience supporting Qualified Person release or clinical trial supply to studies outside the United States.
Experience with oligonucleotide, peptide, or biologic modalities and/or sterile drug product.
Experience with quality agreements and vendor quality metrics programs.

Responsibilities

Interact with company personnel to obtain information needed to support early phase clinical programs.
Serve as the day-to-day QA contact for contract manufacturers, testing laboratories, clinical packaging and labeling providers, and clinical supply depots.
Review and approve vendor documentation for early phase clinical material, including batch records, testing records, certificates of analysis, labels, protocols, and reports, against approved specifications and applicable IND/CTA/IMPD requirements.
Review clinical label text and vendor labeling records, including label reconciliation and verification of required regional content.
Perform investigational product lot disposition under applicable quality agreements and generate certificates of compliance as necessary.
Assemble and review documentation packages supporting Qualified Person release of product supplied to studies outside the United States, as assigned.
Collaborate with vendors on quality events and non-conformances, review deviations, OOS/OOT results, and investigations, and track events through timely closure.
Review vendor change notifications and support assessment of their impact on investigational product.
Review vendor stability protocols, reports, and data for early phase material, as assigned.
Support evaluation of shipping and storage temperature excursions affecting investigational product at vendors, depots, and clinical sites.
Support vendor qualification, including questionnaires, audit scheduling and logistics, audit response tracking, and quality agreement record maintenance.
Support vendor technical transfers by reviewing related documentation, as assigned.
Help track vendor quality metrics, including batch record review cycle time, quality event aging, and right-first-time performance, and notify QA management of performance issues.
Assist with preparation, updating, review, and routing of company procedural documents.
Scan and upload executed documents to the EDMS, categorize them, and route them for verification or approval.
Draft, review, and approve SOPs and work instructions as needed.
Maintain knowledge of compliance expectations and regulations for early phase drug development and investigational product supply.
Assist with other QA duties as needed.