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).
STEMHUNTER provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
