Quality Assurance Specialist (Raw Materials)

ZipRecruiter; Verona; In loco; EUR 55.000 - 75.000; Tempo pieno

Descrizione del lavoro

A leading biopharmaceutical company is seeking a Quality Assurance Specialist to support its raw materials program. The successful candidate will ensure compliance with quality standards by reviewing documentation, performing lot dispositions, and collaborating with suppliers. This opportunity is ideal for professionals with experience in quality assurance in the biotech or pharmaceutical industry, looking to contribute to innovative therapeutics.

Competenze

• At least 3 years of QA experience in biotech or pharma.
• Knowledge of GMP, GCP, GLP, ICH, and FDA guidelines.
• Experience with electronic document management systems.

Mansioni

• Review and approve incoming raw material documentation and perform lot disposition.
• Capture quality data and generate metrics for suppliers.
• Assist with raw material qualification reviews.

Conoscenze

Communication

Organizational skills

Attention to detail

Formazione

BSc/BA in chemistry, biology, biochemistry, or related field

Strumenti

Adobe Acrobat

Microsoft Office

SmartSheet

Descrizione del lavoro

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines to treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient delivery methods, Arrowhead therapies trigger RNA interference (RNAi) to induce rapid, deep, and durable knockdown of target genes. RNAi is a natural mechanism in cells that inhibits gene expression, affecting protein production. Arrowhead's therapeutics leverage this pathway to address diseases, especially those with a genetic basis involving overproduction of proteins.

Headquartered in Pasadena, CA, with R&D teams in Madison, WI, and San Diego, CA, our team is composed of innovative, science-driven professionals committed to bringing new therapies to patients.

The Position

This role provides quality assurance support for the raw materials program. Responsibilities include reviewing raw material supplier documentation, performing lot disposition, capturing quality data, and generating metrics. The role involves interaction with internal teams and contract organizations to support pre-clinical, clinical, and commercial programs.

Responsibilities

• Review and approve incoming raw material documentation and perform lot disposition.
• Collaborate with suppliers on quality issues and non-conformances.
• Request and review supporting documentation such as production records, CoA, CoC, BSE/TSE statements.
• Update raw material specifications during onboarding and periodic reviews.
• Capture quality data and generate metrics for suppliers.
• Assist with raw material qualification reviews.
• Manage documentation in EDMS, including scanning, uploading, and routing for approval.
• Assist with procedural document updates and other QA duties as needed.

Requirements

• BSc/BA in chemistry, biology, biochemistry, or related field.
• At least 3 years of QA experience in biotech or pharma, focusing on raw material release.
• Knowledge of GMP, GCP, GLP, ICH, and FDA guidelines.
• Experience with electronic document management systems.
• Proficiency in Adobe Acrobat, Microsoft Office, and SmartSheet.
• Strong communication, organizational, and attention to detail skills.
• Ability to work independently and manage priorities in a fast-paced environment.

The salary range for this position in Wisconsin is $65,000—$80,000 USD. Arrowhead offers competitive salaries and benefits. Applicants must have authorization to work in the US.