Senior Specialist, QA (Mfg Support)
Core
Provide Quality Assurance oversight for manufacturing activities in a GMP biopharmaceutical contract manufacturing facility, ensuring compliance with regulatory and internal quality standards.
Role type
Senior Specialist, QA (Manufacturing Support)
Builds
Biopharmaceutical products under GMP regulations
Domain
Biopharmaceuticals / Contract Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, quality management systems, deviation investigation, change control, CAPA processes, batch record review, regulatory guideline knowledge (FDA/EMA/ICH), analytical problem-solving
Preferred skills
Internal GxP auditing, Qualified Trainer competencies, project management
Technologies
GxP standards, batch record systems, logbook management
Responsibilities
Review and approve SOPs, protocols, reports, and batch records; Evaluate batch records and logbooks to support batch disposition; Participate in or lead deviation investigations, change controls, and CAPA processes; Identify and resolve quality and operational issues; Assist in regulatory inspections and customer audits; Manage small-scale projects
Seniority
Senior, hands-on IC