Job Purpose
To perform and document quality control testing of raw materials, packaging materials, in-process samples, finished products, water and other required samples according to approved specifications, methods, SOPs and GMP requirements.
Key Responsibilities
· Receive, identify, sample and test raw materials, packaging materials, in-process materials and finished products according to approved procedures.
· Perform physical, chemical and analytical testing as assigned.
· Accurately record test results, calculations, observations and laboratory activities in approved records.
· Operate laboratory instruments according to approved SOPs and laboratory procedures.
· Maintain laboratory equipment, work areas, reagents, standards and reference materials in appropriate condition.
· Monitor calibration and qualification status of laboratory equipment and report any status issues.
· Support stability studies and stability sample management as assigned.
· Report abnormal, out-of-specification (OOS) or out-of-trend (OOT) results promptly and participate in investigations according to approved procedures.
· Maintain laboratory data integrity, traceability and good documentation practices.
· Coordinate with QA regarding investigations, deviations and quality trends.
· Follow laboratory safety, chemical handling, hygiene and GMP requirements.
· Support preparation for internal and regulatory inspections and audits.