QA System Associate-Bioscience
Core
Support the Quality Management System (QMS) in a regulated pharmaceutical API and medical device component manufacturing environment to ensure compliance with cGMP and regulatory requirements.
Role type
Associate-level Quality Systems Specialist
Builds
Pharmaceutical Quality Management System
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
dashboards & analysis
Required skills
Knowledge of cGMP, document control, deviation investigation, CAPA, validation protocols, regulatory guidelines (ICH Q7/Q9/Q10, 21 CFR)
Preferred skills
Experience in pharmaceutical/biotech/medical device, familiarity with electronic QMS/LIMS/ERP/MES, knowledge of Data Integrity/ALCOA+
Technologies
Electronic QMS, LIMS, ERP, MES, Document Management Systems
Responsibilities
Maintain controlled documents (SOPs, specifications, validation protocols), monitor deviations and investigations, support validation and qualification programs, promote quality culture and compliance
Seniority
Associate, entry-level IC
