Associate Specialist, Quality Lab
Core
Perform analytical testing of pharmaceutical materials, in-process samples, and environmental monitoring to ensure quality and compliance within a Quality Lab.
Role type
Associate Specialist, Quality Lab (Chemist)
Builds
Drug substances and finished products
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical Instrumentation, Analytical Method Development, Analytical Testing, Bioburden Testing, Chemical Analysis, Environmental Monitoring, GMP Compliance, Karl Fischer Titrations, Laboratory Analysis, Laboratory Maintenance, Microbiology Research, New Product Introduction (NPI), Technical Transfer
Preferred skills
None stated
Technologies
None stated
Responsibilities
Perform analytical testing of incoming materials, in-process samples, cleaning samples, environmental monitoring samples, utility systems, intermediates and finished drug substances/products; Participate in analytical/microbiological method transfer/validation/verification, new product introduction and equipment qualification; Assist in conducting laboratory investigations; Provide inputs for development and revision of Analytical Standards, SOPs, Work Instructions and GMP documents; Maintain laboratory housekeeping, inventory and ensure inspection readiness; Execute quality and laboratory improvement initiatives; Perform equipment preventive maintenance and calibration; Review laboratory documents.
Seniority
Associate, entry-level to mid-level
