Rejuvenate Bio is looking for a highly motivated individual to join our energetic team and accelerate the development of our therapies. The position will directly support efforts to drive forward our future commercial offerings by developing our GMP process. The Quality Control Associate will be responsible for independently reviewing, documenting and approving internal and external testing data, and supporting documentation for CoA and CoT release. Some examples of testing includes: myco, bioburdern, sterility, genomic ID, capsid ID, titer etc. This role reports directly to the Sr. Director of CMC.
• Review and approval of ancillary documentation associated with laboratory testing including logbooks, forms, raw data, etc.
• Assists in setting process specifications based on raw data review.
• Works with QA to close out quality events related to release testing or protocol development at external labs.
• Assist with the review of laboratory records and associated documentation required for lot release.
• Work with CTL and CMO to coordinate shipping and testing of samples for lot release, investigations, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT.
• Work with CMC and regulatory as needed to author sections for IND/BLA filings/amendments.
• Responsible for the accurate, timely and compliant execution of assigned projects, related documentation, and any other tasks as assigned by management.
• Bachelor's degree in Biology, Chemistry, or relevant Life Sciences field.
• 3+ years of relevant quality experience in the Biotech or pharmaceutical industry.
• Working knowledge of industry guideline including GxP, cGMPS, ICH, CFR, and global regulations as appropriate.
• Experience with Quality Systems (change control, deviation, and investigation) is a plus.
• Prior experience in the gene therapy field is highly preferred.
If interested, email firstname.lastname@example.org with a resume and cover letter. We are located in San Diego California.