Job Description - Quality Control Scientist
Responsibilities:
Conduct analytical tests following QC Lab protocols to assess raw materials, components, and products throughout manufacturing stages.
Participate in method transfer, qualification, validation, and stability studies as per protocols.
Analyze and present data according to GDP and ALCOA principles.
Assist in investigating deviations, OOS/OOT results, CAPA, and related tasks.
Develop, review, and update SOPs and ATMs as needed.
Calibrate, validate, and maintain lab equipment.
Ensure accuracy and regulatory compliance of lab data.
Fulfill other assigned duties.
Qualifications:
1-3 years' QC experience, preferably in pharmaceuticals with cGMP knowledge.
Considerable expertise relevant to QC analytical methods used for cell therapy
manufacturing including qPCR/dPCR, ELISA, flow cytometry or cell-based assays in a
GMP environment.
Experience in technical writing and strong communication skills.
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