Overview
Bioassay Quality Control Specialist Role Overview
The ideal candidate will have advanced training in bioassays analysis with 2 to 5 years of proven experience in quality control within a regulated pharmaceutical environment.
Responsibilities
- Perform cell proliferation methods and other bioassays to verify the potency of biotechnology products, following USP and EP methods.
- Maintain detailed and contemporaneous records in laboratory notebooks, logbooks, or electronic systems.
- Participate in quality system activities including investigation of out-of-specification results, deviation reporting, and support in corrective action implementation.
- Maintain laboratory equipment calibration and functionality and promptly report any malfunctions or maintenance needs.
- Follow all biosafety and safety protocols contributing to maintaining a clean, organized, and compliant laboratory environment.
- Collaborate effectively with QA, production, validation, and other cross-functional teams to support quality assurance and compliance.
Qualifications
Advanced training in bioassays analysis.Practical expertise in bioassays used in biotechnology.A strong knowledge of data integrity principles and documentation practices.Experience in managing quality systems including investigations, deviation reporting, and corrective action implementation.Strong organizational skills and the ability to work independently while ensuring strict compliance with regulatory requirements.Benefits
We Offer : This is an excellent opportunity to join our team as a Bioassay Quality Control Specialist. The selected candidate will work closely with our quality assurance team to ensure the highest standards of quality in our biotechnology products.
Additional Information
Additional Information : This is a contract position with an indefinite duration. The working hours will be 40 hours per week, with flexibility to organize shifts.
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