Biotech QA Specialist II – GMP Documentation & Release

Arrowhead Pharmaceuticals, Inc.; Verona (WI); On-site; USD 70,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefit package

Job summary

Arrowhead Pharmaceuticals, Inc. in Wisconsin is seeking a Specialist II to join the Quality Assurance team.

The role supports preclinical, clinical, and commercial drug development by reviewing batch records, analytical data, and supporting cGMP compliance. The ideal candidate will have a BS/BA in a scientific field, at least 3 years in QA within biotech/pharma, strong communication skills, and the ability to work independently in a fast-paced environment.

Qualifications

• 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 work independently with minimal supervision and manage priorities in a fast-paced environment.

Responsibilities

• Interact with representatives from other departments to obtain information for review of documentation.
• Review and approve analytical testing data and final reports from internal and external sources with minimal supervision.
• Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
• Review and approve internally generated raw material data and documentation with minimal supervision.
• Perform lot disposition and release of raw materials with minimal supervision.
• Perform room releases as required.
• Perform QA on the floor as required.
• Assist with investigations and deviations as appropriate with minimal supervision.
• Organization and control of project related documentation.
• Issue, review, and reconcile controlled forms.
• Review, verify, and reconcile labels.
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Assist with Good Documentation Practices, GMP, and data integrity training as needed.
• Additional duties as assigned.

Skills

Attention to detail

Communication skills

Independent worker

Organizational skills

Prioritization

Education

BS/BA in chemistry/biology/biochemistry

Tools

EDMS

Smartsheet

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. in Wisconsin is seeking a Specialist II to join the Quality Assurance team.

The role supports preclinical, clinical, and commercial drug development by reviewing batch records, analytical data, and supporting cGMP compliance. The ideal candidate will have a BS/BA in a scientific field, at least 3 years in QA within biotech/pharma, strong communication skills, and the ability to work independently in a fast-paced environment.