Quality Assurance Specialist II
QA Specialist II at Arrowhead Pharmaceuticals provides quality oversight of GLP/GCLP-compliant bioanalytical and biomarker studies: conducting audits (including chromatography/LIMS raw data), reviewing protocols and validation reports, drafting CAPAs, and supporting regulatory readiness. Core focus is pharmaceutical QA under FDA/EMA, OECD GLP, ICH M10, and 21 CFR Part 11.
- Compensation
- $70K–$85K / yr
- Location
- Madison, Wisconsin, United States
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 3+ years
- Category
- Qa
- Posted
Skills
Must have
- Bachelor's degree in a scientific field
- 3+ years of GLP/GCLP QA experience in pharma or CRO settings
- Knowledge of OECD GLP, FDA/EMA regulations, ICH M10, and 21 CFR Part 11
- Working experience auditing HPLC, LC-MS/MS, and ELISA
- Excellent communication skills and experience drafting audit reports
- 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 and manage priorities in a fast-paced environment
- Current, valid authorization to work in the country where the role is located
Nice to have
- Master's degree
- ASQ Certified Quality Auditor (CQA) or equivalent certification
- Experience supporting biologics, gene therapies, or biomarkers in oncology or rare disease programs
- Familiarity with electronic systems including Veeva Vault QMS, LIMS, and eTMF
Full description
Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
Provides quality oversight for GLP/GCLP-compliant bioanalytical and biomarker activities. The QA Specialist II is responsible for conducting audits, collaborating with stakeholders, and ensuring that studies are compliant with regulatory standards.
Responsibilities
- Independently plan, conduct, and report study-specific audits, including method validation and sample analysis phases.
- Review and approve study protocols, validation reports, and analytical plans for QA compliance.
- Audit raw data (chromatography, LIMS) for integrity and regulatory alignment.
- Support regulatory readiness efforts, including preparing responses to audit findings.
- Manage QA activities across assigned clinical and nonclinical studies.
- Lead non-conformance investigations and draft comprehensive CAPAs.
- Proactively identify areas for quality improvement and update audit tools or SOPs accordingly.
- Serve as QA liaison for assigned projects and ensure proper documentation in systems like LIMS or Vault.
- May mentor QA Specialist I personnel and contribute to their onboarding.