Job Title: Quality Control Analyst
Seeking a Quality Control Analyst for a leading biotechnology company currently engaged in developing novel oncology therapies. They have an exciting pipeline consisting of oncology products both clinical and pre-clinical trials. They are looking to bring on a highly motivated Quality Control Analyst to join their team in San Diego, CA. This is a contract role with possible extension and benefits are offered.
Responsibilities:
- Assist in drafting SOP's, test methods, technical reports, and validation protocols
- Assist with verification and review of quality control test data which include (Drug Substance (DS) and Drug Product (DP) in-process, release, reference standard and stability data generated CMOs
- Verification of data in analytical reports and regulatory analytical files
- Reporting of data trends
- Execute change controls
- Review investigations/data from CMOs
- Assist in method qualification, validation, and method improvements for variety of products
Qualifications:
- Bachelor's Degree in Life Sciences or Related Scientific Field
- Quality control experience in the pharmaceutical industry supporting cGMP areas
- Experience working with Biologics
- Complete understanding of ICH guidelines, regulatory guidelines, and GMPs
Benefits:
- Inspiring company mission
- Dynamic and encouraging company culture
- Supportive management
Please reach out and apply if you are interested!
