Microbiology QC Supervisor
Brooksville, FL US
Microbiology QC Supervisor
Title: Microbiology QC Supervisor
Location: Brooksville, FL
Shift: Mon-Fri 8am-5pm
Salary: $85k and up depending on experience
Employment Type: Direct Placement
Our Client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.
The QC department is responsible for microbiological and analytical cGMP testing of sterile injectable 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 Supervisor coordinates and oversees all activities in the QC Chemistry and Microbiology department 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 Corporate 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:
- Evaluate and implement new analytical technologies, computer systems, software, HPLC and GC data systems, instrumentation, and updated compendia methodologies
- Coordinate scheduling and assigning weekly tasks for departmental personnel, including stability program.
- Review data sheets and direct report laboratory notebooks for accuracy and compliance to microbiological methods.
- Supervise and assist in the use of analytical equipment and techniques for testing.
- Provide technical leadership in analyzing and microbiological techniques.
- Oversee the performance of product testing for release and stability; Author qualification reports and technical methods summarizing test results. Ensure testing and associated documentation is performed and reviewed in a timely manner with high accuracy and reliability.
- Ensure direct reports meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Corporate Policies.
- Revise and review standard operating procedures (SOPs) for laboratory; revisions may be related to procedural improvements, customer requests and/or audit observations.
- Oversee and participate in OOS investigations and departmental quality events as they occur.
- Ensure the inventory and tracking records of supplies and equipment is accurate.
- Actively examine and research current work practices to propose process improvements and increase efficiencies.
- Interact with other departments, including quality assurance and production, to ensure a smooth overall workflow.
- 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.
- Bachelor s degree in Chemistry, Biochemistry, Microbiology.
- Minimum of 5 years experience in an Analytical or Microbiology QC role supporting a pharmaceutical manufacturing operation.
- Microbiology background experience with sterility, bioburden, EM, CCIT, BET,
- Minimum of 1 year supervision experience
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.