QA Specialist II - Operations
Core
Provide real-time, on-the-floor Quality Assurance support for GMP manufacturing operations, ensuring compliance with standards and data integrity principles.
Role type
Mid-level IC Quality Assurance Specialist (GMP Manufacturing)
Builds
Compliant pharmaceutical manufacturing processes and documentation
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | 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 requirements, SAP/LIMS/TrackWise/Syncade familiarity
Technologies
SAP, LIMS, TrackWise, Syncade
Responsibilities
Conduct daily QA presence in GMP areas to review documentation and observe 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 Quality in cross-functional teams; Support inspection readiness
Seniority
Mid-level, hands-on IC
