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Job: QC Analyst II, CoImmune Inc., Durham, NC
QC Analyst II
Durham, NC 99999 United States
SCOPE: The individual will conduct routine and non-routine analyses of in-process and finished formulations according to QC test methods. The individual will also assist in the development/qualification or validation of in-process and release assays utilized in Quality Control and assist in preparing necessary documentation. All activities will be performed in a cGMP compliant environment
• Responsible for conducting routine and non-routine analyses of in-process, and finished formulations according to approved QC procedures.
• Perform environmental monitoring of air, surfaces, and personnel in Manufacturing.
• Enumerate bacterial and fungal colonies from Manufacturing environmental monitoring samples and enter results into the MODA system
• Compile data for technical reports
• Author Item specifications
• Write and update standard test methods and standard operating procedures
• Assist in the review of data obtained for compliance to specifications and report abnormalities
• Participate in assay validation/qualification and assay transfer.
• Strive to improve assays for better efficiency and consistent results
• Assist in the review of QC test results to ensure that specifications are met and that testing has been performed according to cGMP requirements. Make recommendations for any corrective actions.
• Report or investigate any lab result that is out of specification
• Perform other duties as required
• BS degree in Molecular Biology, Cell Biology, or Biochemistry
• Minimum 5 years biotech/pharmaceutical experience in quality control or molecular biology.
• Must have experience with the documentation of quality control systems in a biotech/pharmaceutical setting
• Must have experience in molecular biology
• Must have strong computer skills
• Must be able to communicate effectively with co-workers
• Must have initiative, high attention to detail, and the ability to multi-task
• Ability and willingness to be regularly, predictably, and reliably at work
(see job description above)
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