Associate Specialist, Quality Control (WDA)
Core
Perform analytical testing of incoming materials, in-process samples, cleaning samples, environmental monitoring samples, utility systems, intermediates and finished drug substances/products according to approved procedures.
Role type
Associate Specialist, Quality Control (Incoming Laboratory)
Builds
Drug substances and products
Domain
Biopharma / Pharmaceutical Manufacturing
Required skills
Analytical Instrumentation, Analytical Method Development, Analytical Problem Solving, Bioburden Testing, Chemical Analysis, Data Analysis, Karl Fischer Titrations, Laboratory Instrumentation, Laboratory Techniques, Microbiology Research, Technical Transfer, Ultraviolet Visible Spectroscopy
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 method transfer/ validation/ verification, new product introduction and equipment qualification; Assist in conducting laboratory investigations; Provide inputs for the development and revision of Analytical Standards, Standard Operating Procedures, Work Instructions and other GMP documents; Maintain proper laboratory housekeeping, laboratory inventory and ensure inspection readiness; Execute quality and laboratory improvement initiatives and other special projects; Perform equipment preventive maintenance and calibration; Perform review of laboratory documents such as orphan data check and equipment logs.
Seniority
Entry-level (0-3 years experience)