Key Responsibilities:

Perform routine quality control testing on biotechnology products, including but not limited to: PCR, ELISA, and cell-based assays.
Review and analyze test results for accuracy and compliance with established specifications and regulations.
Maintain and calibrate laboratory equipment to ensure accuracy and precision in testing.
Develop and validate new analytical methods and procedures as needed.
Troubleshoot and resolve any technical issues that arise during testing.
Maintain accurate and detailed records of all testing procedures and results.
Collaborate with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs to ensure timely release of products.
Monitor and maintain inventory of laboratory supplies and reagents.
Participate in internal and external audits and assist with implementing corrective actions.
Stay current with industry advancements and regulatory requirements, and make recommendations for process improvements.

Qualifications:

Bachelor's or Master's degree in Biology, Biochemistry, or related field.
Minimum of 3 years of experience in a quality control role within the biotechnology industry.
Strong understanding of quality control testing methodologies and techniques.
Experience with PCR, ELISA, and cell-based assays is required.
Knowledge of regulatory guidelines and standards including FDA, ISO, and GLP.
Excellent analytical and problem-solving skills.
Detail-oriented with a high level of accuracy and precision in work.
Ability to work independently and in a team environment.
Excellent communication and interpersonal skills.
Proficient in Microsoft Office and data analysis software.

We look forward to reviewing your application.

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