Quality Assurance Specialist II - External Quality
About The Position
Arrowhead Pharmaceuticals, Inc. is a commercial stage biopharmaceutical company focused on developing medicines that treat intractable diseases by silencing the genes that cause them. The company utilizes a broad portfolio of RNA chemistries and efficient modes of delivery to create therapies that trigger the RNA interference mechanism for rapid, deep, and durable knockdown of target genes. Arrowhead's RNAi-based therapeutics leverage the natural pathway of gene silencing. The company is dedicated to developing innovative drugs for diseases with a genetic basis, often characterized by the overproduction of disease-involved proteins. Their versatile RNAi technologies enable them to potentially address conditions in any therapeutic area and pursue disease targets not addressable by small molecules and biologics. Arrowhead is a leader in bringing RNAi to address diseases outside of the liver, with a clinical pipeline targeting liver and lung diseases and a promising preclinical pipeline. The purpose of this position is to provide quality assurance support to programs that use contract development, manufacturing, and testing organizations. The role involves reviewing vendor documentation, performing lot disposition according to applicable quality agreements, and capturing quality data to generate vendor metrics. The incumbent will interact with internal departments and multiple contract organizations to support commercial, pre-clinical, and clinical development programs.
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.
- Candidates must have current, valid authorization to work in the country where this role is located.
Nice To Haves
- 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.
Responsibilities
- Interact with personnel companywide to obtain the necessary information and details to provide quality assurance support of development, clinical, and commercial programs.
- Review and approve vendor generated documentation, including but not limited to, executed batch records, testing records, certificates of analysis (CoA), labels, protocols, and reports.
- Collaborate with vendors on quality events and non-conformances as outlined in the applicable quality agreement.
- Perform lot disposition and generate certificates of compliance (CoC) as necessary.
- Assist with preparation, update, review, and routing of Arrowhead procedural documents.
- Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
- Assist with QA duties as needed.
Benefits
- competitive salaries
- excellent benefit package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
