We are looking for a Supervisor for our QC Virology team! This position is a Monday-Friday, 8am-4:30pm shift. This role is responsible for overseeing routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured commercial and clinical products according to cGMP, ICH guidelines, and associated standard operating procedures. The QCV Supervisor will be responsible for sample chain of custody, sample processing, testing in-house as well as external and test data reporting.

As a Supervisor of QC Virology, a typical day might include the following:

· Supervise the contract lab testing program for cell bank and unprocessed bulk (including the cGMP aspect).

· Supervise the in-house testing activities.

· Ensure cGMP operation (including the CBE30 Submission and Regulatory Inspection).

· Regulatory Document Review – Virology section (IND, BLA) for accuracy of test results.

· Define business operation model for the virology lab (i.e. capacity planning, activity scheduling, sample projection, and metrics.

· Proficient in virus and Mycoplasma testing according to ICH, USP, and E.P.

· Proficient in cGMP practices in all aspects of laboratory assignments.

· Collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities.

· Apply basic and advanced troubleshooting methods as well as problem solving tools such as A3.

· Initiate, compile, and perform lab investigations that include reviewing documents, conducting internal and external interviews, and tracking information.

· Oversee virus and mycoplasma assays at all levels of complexity to support manufactured products.

· Oversee data trending, data review, metrics and lab maintenance activities (e.g. cleaning).

· Oversee collection, data entry and generation of reports from electronic systems.

· Review and evaluate Lab data for conformance to cGMP and specifications and assist with investigation of laboratory deviations.

· Revise and update standard operation procedures. Display good manufacturing practices, good laboratory practices, and ensurie quality and safety of manufactured products.

This role might be for you if you:

· Work independently with little supervision and manage a team.

· Enforce established safety and environmental guidelines and procedures for all work performed by immediately reporting safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.

· Foster a positive safety culture in which no one gets hurt.

· Maintain laboratory in an inspection-ready state and cGMP compliant manner at all times.

To be considered for a Supervisor of QC Virology you must be willing and able to work Monday-Friday, 8am-4:30pm. This position requires a BS/BA in Virology, Cell Biology, Microbiology, Biochemistry, or related Science, with 5 years working in GMP virology lab or related experience.Relevant experience may be substituted in lieu of educational requirement.