Senior Specialist, QA Technical Operations
Core
Support investigations, qualification, validation, and New Product Introductions within Multi Product Cell Culture (MPCC) and supporting areas for drug substance manufacturing.
Role type
Senior Specialist, QA Technical Operations (Biopharmaceuticals)
Builds
GMP-compliant drug substance products for patients with serious diseases
Domain
Biopharmaceuticals / Cell Culture / Quality Assurance
Required skills
cGMP knowledge, deviation management, change control, validation protocols, GMP documentation review, APQR review, SAP/Maximo/MES support, project support
Preferred skills
None stated
Technologies
SAP, Maximo, Manufacturing Execution System (MES), Service Now, ALM
Responsibilities
Support review and approval of investigations within MPCC; Facilitate investigation triage and daily meetings; Author and approve QA procedures; Support change controls, NPI, and tech transfer projects; Provide QA support for validation and qualification activities; Review and approve Annual Product Quality Review (APQR) reports; Review and approve GMP documentation (validation plans, protocols, SOPs, etc.)
Seniority
Senior, hands-on IC