QC Specialist III
Under the supervision of the QC Microbiology Supervisor, the candidate is responsible for coordination and execution of activities for quality control programs including the following responsibilities:
- Assist in the establishment and ongoing management of the QC Microbiology program.
- Perform technical writing of procedures, protocols and reports such as action excursions and quality events.
- Experience with FDA, USP and ISO regulations.
- Coordinate, assemble, and route documentation to support QC document review and approval as required by Quality Systems Management.
- Prepare and provide timely and accurate reports and assessments of assigned project (s) and quality metrics to the QC Management.
- Participate in problem solving exercises to identify the potential root causes.
- Perform Environmental Monitoring duties to ensure that the GMP processing area is in compliance with regulatory guidelines.
- Assist with performing microbiological testing of raw materials, In-process and utilities samples.
- Responsible for maintaining laboratory equipment in accordance with QC procedures,
- Holds specific technical expertise and assumes a role of support to Supervisor.
- Able to solve problems independently but will seek out advice from others to assure proper outcome.
- Excellent knowledge of aseptic techniques.
- Be able to train new employees and mentor junior employees.
- Coordination of process or project management teams without direct supervision of staff.
- Must be able to clearly and concisely document results and communicate them clearly to a variety of teams. Including data review in a timely manner.
- Must be able to work with multidisciplinary team and represent the group.
- Completes projects on time by managing personal work schedule as well as cooperate and
coordinates with members of a team to obtain and/or deliver the necessary data on time.
- Must evaluate and identify more efficient work processes. Such as contribute to the
development of new practices by identifying better approaches to some regular problems.
- Experience with enterprise applications (example: LIMS, Trackwise, Documentation, SAP) preferred.
- The employee is required to stand, up to 6 hours a day; walk; reach with hands and arm and stoop, kneel, crouch, or crawl
- The employee must lift and or move up to 20 pounds occasionally.
- Associate degree in science with a minimum of 6 years of experience.
- Bachelor’s degree in sciences or engineering with a minimum of 5 years of biopharmaceutical experience.