Job Summary
The role involves conducting routine quality control examinations on various materials including raw, in-process, and drug products, as well as stability samples. The position emphasizes microbiological and molecular testing, environmental monitoring, and utilities assessment, ensuring compliance with quality standards.
Responsibilities
- Conduct quality control tests on raw materials, in-process items, drug products, and stability samples.
- Perform microbiological and molecular assays as part of the quality testing process.
- Engage in environmental monitoring and utilities testing to ensure a compliant testing environment.
- Review and document QC results, providing thorough reports on findings.
- Investigate deviations and out-of-specification results to maintain quality standards.
- Ensure proper maintenance of laboratory equipment and accurate documentation practices.
- Assist with method transfers and maintain readiness for audits.
Qualifications
- High school diploma with a minimum of four years in a cGMP laboratory setting.
- Associate degree with two to four years of relevant industry experience.
- Bachelor’s degree with zero to two years of industry exposure.
- Basic understanding of cGMP regulations or prior laboratory experience is essential.
- Preferred: Experience in a cGMP laboratory, microbiological testing, or environmental monitoring.
- Proficient in Microsoft Office applications and Laboratory Information Management Systems (LIMS).
