Senior Specialist, QA Operations – 1st Shift
Core
Review batch records, release materials, assess manufacturing compliance, and lead deviation investigations to ensure GMP adherence in pharmaceutical manufacturing.
Role type
Senior Specialist, QA Operations (Pharmaceutical Manufacturing)
Builds
Compliant pharmaceutical manufacturing processes and quality systems
Domain
Healthcare / Pharmaceutical Manufacturing
Required skills
GMP compliance, deviation investigation, batch record review, SOP development, continuous improvement, quality system management, retain inspection, training delivery
Preferred skills
Knowledge of cGMP, ICH, Pharmacopoeia, ISO, IPEC, MS Office suite (Word, Excel, Access, Project)
Responsibilities
Review in-process and finished product batch records; Release intermediate materials; Assess manufacturing operations for GMP compliance; Lead evaluation and triage of deviations and unplanned activities; Participate in deviation investigations; Identify and lead continuous improvement projects; Maintain QA retain inventory and perform inspections; Conduct QA operations training; Develop and maintain SOPs and training modules
