Sr Associate Quality Assurance - PQA - 2nd Shift
Core
Sr Associate PQA ensures 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 individual contributor Quality Assurance Associate (Pharmaceutical 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, audit support, regulatory documentation, process compliance, quality system alignment, risk alerting
Preferred skills
Biotechnology plant startup experience, upstream/downstream manufacturing knowledge, EBR/MES/Delta V systems proficiency, GMP testing lab support, continuous improvement implementation
Technologies
EBR, MES, Delta V, Electronic Quality Systems
Responsibilities
Support facility commissioning and equipment qualification; oversee new product introduction quality; ensure cGMP/GDP compliance for manufacturing, testing, and distribution; drive closure of deviations, investigations, and CAPA; oversee on-the-floor analytical testing; represent PQA during audits and regulatory inspections.
Seniority
Senior, hands-on IC
