QC Analytical 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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