Sr QC Manager, Microbiology

Employer
The Denzel Group
Location
Ellicott City, Maryland, US
Salary
Competitive
Posted
May 01, 2021
Closes
May 08, 2021
Ref
2150636971
Employment Type
Full time
Salary Type
Salary
The Denzel Group, an award-winning search firm, has been chosen to work with an industry leader in Baltimore on their quest for a talented Sr. Microbiology QC Manager. In this role you will manage staff, documentation, environmental and utility programs, and new microbiological projects.

Responsibilities

Manage scheduling and execution of the environmental monitoring testing program, utility testing program, raw material, in-process, and product release testing requirements.
Project Management for new projects: define scope of work, and ensure adherence to time and budget.
Manage lab staff.
Serve as the technical subject matter expert on microbiological assays and techniques.
Author, review, and approve SOPs, validation protocols, investigations, and batch record specifications.
Work with staff to author Microbiology deviations, CAPA, OOS, and OOL investigations.

Qualifications

Minimum of BS degree in Microbiology/Biology or related field.
10+ years' relevant experience, 5+ years' supervisory responsibilities in Pharmaceutical industry with emphasis in aseptic processing, QC microbiology, environmental monitoring, water systems, cGMP, and validation.
Hands-on experience with microbiological methods such as Bacteriostasis and Fungistasis, Enhancement and Inhibition, LAL, Sterility, and Bioburden Testing.
Experience performing microbiology investigations.

KW: Manager, supervisor, lead, microbiology, QC, quality control, environmental monitoring, GMP, investigations, deviations, CAPA, SOP, protocols, batch review, project management

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