Job Description:
Client needs a Sterility Assurance Manager level resource. Looking for the resource to start ASAP. Work cross-functionally to develop processes for the aseptic manufacture of parenteral drugs. This includes the following contamination control programs: clean room and isolator design and qualification, media fill programs, development of disinfection practices, environmental and critical utilities monitoring, gowning programs and the subsequent training of operators on the aseptic technique for the process, including OJT and Media Fill qualification. Author and Review SOP’s, OJT’s, Job Aids, Batch Records and Regulatory Submissions.
Qualifications:
- Bachelor of Science Degree in Chemistry, or other science related field required.
- 15 or more years of relevant experience required.
- 2 or more years of leadership experience in a cGMP environment.
- Lean Leader/Operational Excellence/5S preferred.
- Laboratory Instrument qualification preferred.
- Method validation/transfer preferred.
MO: Sterility Assurance Manager (236722)
#LI-Onsite