Research and Development
NCBiotech Jobs Board ● Connecting North Carolina's life science employers and workforce.
Job: Quality Control Analyst, CoImmune, Inc., Durham, NC
Quality Control Analyst
Durham, NC 27704 United States
CoImmune offers a competitive compensation and benefits package, including but not limited to: medical, dental, and vision insurance, 401(k), and PTO.
Research and Development
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 prepare all necessary documentation. All activities will be performed in a cGMP compliant environment.
- Responsible for conducting routine and non-routine analyses, 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 and trend data and write technical reports.
- Author Item specifications.
- Author 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.
- 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.
Majority of work is sedentary with sitting, standing and bending. Some occasional physical demands such as: pushing, pulling, and lifting up to 30 lbs. Good dexterity and balance required. Work will require working with Biohazardous, small quantities of chemical materials, as well as ultra-cold temperatures while wearing personal protective equipment.
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