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./li>
- 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/li>
- 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.
The requirements listed in this job description are representative of the management’s assignment of essential function, with knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Nothing in this herein restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Furthermore, the job description doesn’t constitute a contract of employment and CoImmune Inc. may exercise its employment-at-will at any time.