On-Site QA Specialist — Biotech (Newark, 4 Days/Week)

Protagonist Therapeutics Inc.; Newark (CA); On-site; USD 130,000 - 160,000; Full time

Benefits offered by this job

Health Care benefits

Flexible Spending Accounts

401(k) Plan

Flexible Vacation Policy

Life Insurance

Job summary

Protagonist Therapeutics, Inc. in Newark, CA, is seeking a Specialist/Senior Specialist, Quality Assurance to perform QA activities in support of GMP manufacturing, including batch record review, deviation review, and regulatory inspections.

Reporting to Head of QA, this role requires travel up to 25% and collaboration with cross-functional teams to ensure GMP compliance and robust quality systems.

Qualifications

• Bachelor’s degree in a scientific or related field required; advanced degrees a plus.

Responsibilities

• Develop quality oversight strategy for selected CMOs and suppliers.

Skills

QA Oversight

GMP Compliance

Regulatory Audits

Cross-functional

Documentation

Education

Bachelor’s Degree

Job description

Protagonist Therapeutics, Inc. in Newark, CA, is seeking a Specialist/Senior Specialist, Quality Assurance to perform QA activities in support of GMP manufacturing, including batch record review, deviation review, and regulatory inspections.

Reporting to Head of QA, this role requires travel up to 25% and collaboration with cross-functional teams to ensure GMP compliance and robust quality systems.