Job Description

Responsibilities:

• Conduct QC analytical testing (e.g., ELISA, Flow Cytometry, PCR) on patient samples, stability samples, controls, and reagent qualifications in a GMP environment.
• Perform non-routine analysis of raw materials, intermediates, and finished product samples.
• Troubleshoot instrumentation and resolve test method issues to ensure testing accuracy.
• Review assays and maintain the laboratory in a state of compliance with GMP standards.
• Write and execute protocols, reports, and SOPs as required.
• Evaluate equipment for purchase and manage installation and qualification of new instruments.
• Assist in the training of QC staff on laboratory methods and practices.
• Apply knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).

Qualifications:

• Bachelor's degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry) or equivalent experience.
• Experience working in a GMP-regulated environment, preferably in Quality Control or a similar role.
• Strong background in QC analytical testing methodologies such as ELISA, Flow Cytometry, and PCR.
• Experience writing and executing protocols, reports, and standard operating procedures (SOPs).

Key Skills:

• Proficiency in troubleshooting laboratory instruments and test methods.
• Solid understanding of cGMPs and GLPs.
• Strong attention to detail and commitment to maintaining compliance.
• Proficiency with Microsoft Office software (Word, Excel, PowerPoint).

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