Senior QA Specialist - Biotech GMP, On-Site 4 Days/Week

Protagonist Therapeutics; Newark (CA); Sur place; USD 130 000 - 160 000; Plein temps

Avantages offerts par ce poste

Health benefits

401(k) Plan

Flexible vacation

Life Insurance

Résumé du poste

Protagonist Therapeutics is seeking a Specialist/Sr. Specialist, Quality Assurance to perform GMP QA activities supporting manufacturing. The role reports to the Head of QA and prioritizes QA GMP support with a risk-based approach, including batch record and deviation reviews.

We are committed to an in-office culture with on-site work in Newark, CA four days per week. The position requires 5+ to 8+ years in biotech/pharma QA and willingness to travel up to 25% (incl. international).

Qualifications

• Bachelor’s Degree in a scientific or related discipline; advanced degrees are a plus.
• 5+ years in biotech/pharmaceutical QA with GMP experience; ASQ is a plus.
• Experience interpreting EU, FDA and ICH regulations and guidance documents.

Responsabilités

• Develop quality oversight strategy for CMOs and QA GMP vendor audits.
• Support regulatory inspections and internal audits; review batch records.
• Review analytical methods, specifications, validation protocols and reports.
• Manage CAPAs and change controls; close CC packages.
• Investigate product complaints, recalls and stock recovery as needed.
• Travel up to 25%, including international travel; work with cross-functional teams.

Connaissances

Excellent communication

Cross-functional collaboration

Quality focus

Attention to detail

Self-motivated

Organizational skills

Formation

Bachelor’s degree in a scientific discipline

Advanced degree a plus

Description du poste

Protagonist Therapeutics is seeking a Specialist/Sr. Specialist, Quality Assurance to perform GMP QA activities supporting manufacturing. The role reports to the Head of QA and prioritizes QA GMP support with a risk-based approach, including batch record and deviation reviews.

We are committed to an in-office culture with on-site work in Newark, CA four days per week. The position requires 5+ to 8+ years in biotech/pharma QA and willingness to travel up to 25% (incl. international).