Director of Microbiology QC leads the groups responsible for providing QC technical expertise, oversight, and testing to support new product development, regulatory submissions, sustaining projects, and the release of commercial products. These groups include Microbiology QC, QC in process control, and Stability. Oversees a team of approximately 50 Micro Associates. Expert on the site in terms of microbiology, physical testing, method and process validation, and legal requirements for producing drugs. Support the production facilities with technical and operational QC support to ensure adherence to cGMP and regulatory requirements both internally and externally. Planning, organizing, and managing the activities will ensure that the group's tasks are completed on time. As a Subject Matter Expert for Quality Microbiology processes, procedures, and analytical techniques, communicate with FDA and other regulatory bodies. Manage the creation and implementation of associated programs to maximize staff, testing, and financial resource efficiency needed to achieve business objectives while adhering to legal constraints.
- Oversees an organization's quality control operations.
- Oversees tasks related to product inspection and testing with assistance.
- Makes ensuring that goods and services are up to par and, when necessary, develops remedial action.
- Creates, executes, and evaluates procedures and guidelines for evaluating goods and services.
- Examines and assesses the current testing procedures, and, when appropriate, makes suggestions for enhancements.
- Enforces adherence to regulations.
- Inspects the materials and goods produced by the company visually and physically.
- Ensures that the quality control department satisfies corporate goals by keeping an eye on the performance of its employees.