QC Microbiology Manager

Employer
The Staffing Resource Group, Inc
Location
Hernando County, Florida, US
Salary
Competitive
Posted
Aug 19, 2021
Closes
Sep 18, 2021
Ref
2389872978
Discipline
Biology
Employment Type
Full time
Salary Type
Salary
Title : QC Micro/Chemistry Manager
Location : Brooksville, FL
Type : Direct Hire
Schedule : M-F
Salary : Competitive, based on Experience
The QC department is responsible for microbiological and analytical cGMP testing of sterile and non-sterile products, raw materials, components and utilities. This includes routine microbiological and analytical testing of products for release and stability, development and validation of microbiological and analytical methods, monitoring and maintaining the laboratory in good quality, assisting in the validation and periodic certification of the manufacturing facility/utilities/equipment, developing and executing equipment protocols, and performing work in a safe, accurate and professional manner. The QC Manager coordinates and oversees all activities in the QC Microbiology and QC Chemistry departments and works closely with manufacturing and Quality Assurance for harmonization between departments. The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Company Policies. Specifically , while working independently, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs), USP/NF, or written work instructions:

Job Requirements:

· Manage all internal and outsourced QC laboratory operations. Provide the primary technical support for the QC laboratory and ensure that all testing and investigation, deviations are performed in a high quality and timely manner.

· Responsible for managing stability programs, and the release of drug substance, and finished drug products.

· Responsible for managing QC department validation and calibration activities.

· Coordinate QC support activities of the sterile manufacturing areas, such as environmental monitoring, in-process sampling, utility sampling and formulation.

· Coordinate QC personnel activities to ensure that all testing and calibrations are completed according to schedule and meet all CGMP requirements.

· Responsible for monitoring instrument qualifications and ensuring that qualifications of analytical instruments are up to date and meet regulatory requirements.

· Develop test protocols, review and write technical reports, write SOP's, and review stability data.

· Perform review of laboratory notebooks for accuracy and compliance to the analytical method.

· Write and perform review of QC reports.

· Review investigations, deviations, and CAPAs; coordinate with impacted departments (client) and QA; create and implement appropriate corrective and preventative actions.

· Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards

· All other duties as assigned by management

Education:

· Bachelor's Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or equivalent with 5 years of experience in sterile pharmaceutical and/or biotechnology manufacturing.

Experience:

· Supervisory experience in the pharmaceutical/biotechnology/medical device field

· Ideal candidate will have sterile fill/finish experience

· Knowledge of microbiological and analytical laboratory techniques

· Knowledge of sterile techniques used in the laboratory

· Experience working in QC laboratory

· Ability to learn new laboratory equipment and techniques

· Excellent verbal and written communication skills

· Knowledge of cGMPs, USP/EU regulations, and ICH guidelines

· Analytical reasoning, root cause analysis and problem solving

· Ability to manage direct reports

· Technical writing: write, read, understand, and interpret technical writing and instructions