Supervisor, Quality Control Microbiology Laboratories

Supervisor, Qc Microbiology Labs

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Position Summary

The Supervisor, Qc Microbiology Labs, is responsible for microbiology laboratory quality control of pharmaceutical manufacturing for West Chester products, the establishment of new product introductions (NPI's), the analysis of raw materials, utilities sampling and testing, and microbiology laboratory support for investigations within West Chester Quality Control. As a member of Qc leadership, the Supervisor will also be responsible for delivering Qc and site quality priorities and initiatives as appropriate, collaborating with manufacturing, supply chain and planning teams to deliver the site priorities.

Job Responsibilities

Ensures that systems and processes owned by their team are in a state of control and are effectively managed and maintained. Assigns responsibilities to ensure that workload is managed within their team, ensuring effective use of resources. Assigns and manages roles and responsibilities within their team to ensure clear accountabilities and high-level performance, that meet or exceed customer needs. Allocates team staffing and manages the utilization of resources to ensure that departmental objectives are met within budget guidelines. Maintains a safe work environment by ensuring that team personnel follow site EHS policies and procedures. Develop and maintain a high performing team of Senior Microbiologists, Microbiology Analysts, and Microbiology Technicians. Coordinates workflow within their Qc team. Directs priorities and testing schedules for staff. Utilizes Lean concepts to drive improvements. Train others on procedures and / or processes. Review, verify, and approve Qc data while monitoring for trends and abnormalities. May author technical trend reports. May serve as Qc lead for investigations involving PET process areas related to Qc processes or data, such as sampling, deviations potentially affecting Qc results, investigational sampling and testing. Support transfer, development and qualification of new methods and processes. Identifies and implements learning and development programs for team members. Ensures that team skills, knowledge, and experience are appropriate and well balanced to meet team needs. Provides feedback to their team, and to other teams that interact with team, to assist with building improved performance. Answer compliance and process questions from others, including regulatory agencies. Communicate policies and procedures to employees. Lead process improvement activities and teams to meet strategic goals including Lean labs and High Performing Labs. Communicate priorities and progress to team on a continuing basis. Ensure that employees have the tools needed to perform their jobs safely. Monitor training of employees to ensure compliance. Facilitates and leads initiatives using new technologies, new policies, or new procedures to improve Qc functions. May perform testing of high complexity methods Serves as the primary link between production and Qc teams. Other duties that support Operations, or Laboratory processes may be assigned. Off-shift support may be required to support the site 24 / 7 Operations