Brammer Bio, LLC is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. Our staff members; are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
The QC Associate I will work in the QC cGMP compliant Laboratories to develop, qualify, and conduct microbiological assays that support quality control of biopharmaceutical products being developed and manufactured at Brammer Bio under contract. Normal working hours will be 7:00 pm - 7:00 am on a shift rotation. Occasional off-shift work/holiday work will be required to support business needs. Duties include performing routine microbiological assays and testing including but not limited to environmental monitoring, bioburden and endotoxin testing. The QC Associate I will also troubleshoot and optimize assays under the supervision of QC Microbiology management . Functions also involve raw data review and document management, maintenance (routine and preventive operation) of equipment, and supporting routine laboratory operations (cleaning the laboroatory, inventory control, etc). The Associate I will be expected to technically interpret, and review data produced from the assays they run.
Conduct routine microbiological assays to support products manufactured by Brammer Bio. These assays must be performed according to written procedures and in compliance with cGMP regulations. 50%
The QC Analyst I will review various microbiological assays as required, conduct data entry into applicable data bases and ensure that data integrity is maintained within the laboratory which includes maintaining complete, contemporaneous and accurate records of all work performed. 15%
Manage reagents and material supply chain, maintain equipment within the QC testing lab, perform cleaning, calibration and preventative maintenance at specified intervals. 10%
Support various site wide and department wide projects as required (examples include new manufacturing area qualifications, new laboratory assay implementation, compliance improvement projects. 15%
Other duties as assigned by supervisor. 10%