Job Description Summary

Performs Quality laboratory microbiological analyses of materials including water testing, finished product testing, raw material testing, environmental monitoring, method validation, media preparation, and special projects according to approved test protocols. Detects, conducts and reports on OOS, NOE, and other investigations and Microbiological Risk Assessments. Performs microbiological audits of facilities and may train others to be Auditors. This role serves as a liaison to other departments and acts as an SME for NCRs. This role is responsible for training less senior Microbiologists at all levels. Has thorough knowledge of, and stays current with, regulatory guidance and compendia relevant to laboratories and pharmaceutical manufacturing.

Job Description

• Independently conducts all types of microbiological analyses (including the most complex analyses with cell cultures) using all laboratory equipment according to approved protocols

• Execute and review day-to-day operations of the Microbiology Lab to ensure that cGMPs, GLP’s and all other applicable compendia requirements are met

• Serves as liaison to other departments for microbiological expertise

• Schedules monitoring and samples for testing/inspection, reviews data and ensures monitoring, testing, and inspection is completed per approved procedures

• Reviews and approves test data and ensures testing is performed based on approved procedures

• Reviews data from pH logs, media prep logs, and incubator logs

• Conducts Microbiological Risk Assessments

• Reviews aberrant or OOS test results, recommends and takes corrective actions, documents investigative findings, and coordinates the approval process of investigations

• May approve testing/inspection results and disposition incoming/in process/finished product

• Records results from tests, interprets colony morphology, and accurately maintains laboratory data

• May perform pour plates techniques and pure culture isolation

Commitment to Diversity, Equity, and Inclusion:

At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.