QA Specialist II - Operations
Core
Provide real-time, on-the-floor Quality Assurance support for GMP operational areas, ensuring compliance with standards and data integrity.
Role type
Senior IC Quality Assurance Specialist (GMP Operations)
Builds
Compliant manufacturing processes and documentation within GMP environments
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
physical/clinical work
Required skills
GMP regulations knowledge, data integrity principles, SOP adherence, equipment status management, compliance issue recognition, documentation accuracy
Preferred skills
cGMP regulations, manufacturing process steps, quality control activities, product/line clearance, SAP/LIMS/TrackWise/Syncade familiarity
Technologies
SAP, LIMS, TrackWise, Syncade
Responsibilities
Conduct daily QA presence to review documentation and observe GMP practices; Partner with Manufacturing teams to ensure GMP compliance; Provide guidance and coaching on GMP behaviors; Support routine and non-routine GMP compliance questions; Escalate complex compliance issues; Respond to QA Hotline calls; Authorize Quality Tag Outs and release equipment from changeover; Apply Data Integrity principles; Represent QA in cross-functional teams; Support inspection readiness.
Seniority
Mid-Senior level, hands-on IC with autonomy and coaching responsibilities
