Sr Associate QA - PQA - 1st Shift
Core
Ensure adherence to GMP quality requirements for bulk drug substance manufacturing and new product introduction, facilitating real-time decision-making between manufacturing and quality staff.
Role type
Senior Associate Quality Assurance (Process Quality Assurance) in biopharmaceutical manufacturing
Builds
Bulk drug substances and new product introductions for oncology, inflammation, general medicine, and rare disease therapies
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
cGMP compliance, deviation investigation, CAPA management, change control, validation oversight, GMP testing lab support, regulatory agency interaction, project management, continuous improvement
Preferred skills
Biotechnology plant startup experience, upstream/downstream manufacturing knowledge, EBR/MES/Delta V systems proficiency, strong organizational skills
Technologies
EBR, MES, Delta V, Electronic Quality Systems
Responsibilities
Support facility commissioning and equipment qualification; oversee cGMP compliance for manufacturing, testing, storage, and distribution; drive closure of deviations, investigations, and change controls; provide on-the-floor guidance for analytical testing; represent PQA during audits and inspections.
Seniority
Senior, hands-on IC