Quality Control Microbiologist
Lexington, KY 40511
This is a direct hire position
PinPoint Solutions is hiring a Quality Control Microbiologist
- The Quality Control Microbiologist will be responsible for assisting with the development of new procedures, performing environmental monitoring, microbiological method validations, and routine testing of raw materials, in-process and finished product samples.
- Write and revise Standard Operating Procedures, Test Procedures, Protocols, Training Modules, Trend Reports, and Forms.
- Review and approve laboratory data.
- Assist with the development and execution of microbiological method validation protocols.
- Perform incoming raw material and component microbiological testing.
- Conduct investigations, determine root cause and applicable CAPAs.
- Lead microbiological related projects to implement new methodologies.
- Perform in-process, finished product release, and stability testing.
- Maintain the laboratory in accordance with SOPs.
- Participate in the validation of plant systems and manufacturing processes.
- Participate on drug product development teams.
- Calibrate, operate and maintain instrumentation for product testing.
- Perform routine environmental monitoring and batch monitoring.
- Perform trend analysis of routine environmental monitoring results.
- Lead training in microbiological methods.
- Other duties as assigned.
- Bachelor’s degree in Microbiology, Biology or related field with at least three years of relevant experience in an FDA regulated cGMP environment; or master’s degree with at least one year of relevant experience; or PhD.
- Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules.
- Experience in an FDA regulated cGMP laboratory environment.
- Understanding of current Good Manufacturing Practices (cGMPs)
- Demonstrated knowledge of pharmaceutical microbiology techniques.
- Experience in developing and validating microbiological methods per USP/EP specifications and guidance’s.
- Team player with well-developed interpersonal and mentoring skills, excellent organizational skills, communication skills, including written documentation skills and presentation skills
HKA Enterprises is a global workforce solutions firm. If you're seeking a new career opportunity or project experience, our recruiters will work to understand your qualifications, experience, and personal goals. At HKA, we recognize the importance of matching employee goals with those of the employer. We strive to seek credibility, satisfaction, and endorsement from all of our applicants. We invite you to take time and search for your next career experience with us! HKA is an EEO Employer who participates in the US Citizenship and Immigration Services E-Verify Program.