This role supports product release for clinical and commercial products, manages quality documentation, and participates in investigations, audits, and process improvements across the organization
Job Summary
This role supports product release for clinical and commercial products, manages quality documentation, and participates in investigations, audits, and process improvements across the organization.
Ensure site adherence to Quality System requirements, cGMP standards, and ICH guidelines.
At PolyPeptide Laboratories, you’ll work on highly technical, meaningful science that directly supports life-changing medicines.
Matching Summary
This role supports product release for clinical and commercial products, manages quality documentation, and participates in investigations, audits, and process improvements across the organization.
Salary
$75k-$83k
Skills & Requirements
Must-have
cGMP manufacturing and testing
deviation investigations
batch record review
SOPs and Material Review Reports
Quality System requirements
FDA and other regulatory agencies
Nice-to-have
continuous improvement
science-driven environment
collaborative
impact in the pharmaceutical industry
Key Requirements
5–7 years of Quality Assurance experience
Bachelor’s degree in Chemistry, Biology, or Pharmaceutical Sciences
Strong understanding of FDA, EMA, ICH, and cGMP regulations