Microbiology Laboratory Supervisor

1 week ago

Rochester, New York, United States Endo International Full time

Job Summary

The Supervisor, Microbiology is responsible for overseeing the day-to-day operations of the Microbiology group, ensuring compliance with cGMPs and GLPs while conducting investigations. This role supports all sites QC and AR&D for Microbiology and Technical issues.

Key Responsibilities

  • Oversee day-to-day operations of the Microbiology Lab to ensure compliance with cGMPs, GLPs, and other applicable compendia requirements.
  • Schedule samples to be tested, review analyst's notebooks/LIMS data, and ensure testing is done per approved procedures.
  • Investigate Alert/Questionable/OOS test results, take corrective actions, document investigation findings, and coordinate approval process in TrackWise.
  • Develop procedures for environmental monitoring programs to ensure cGMP compliance.
  • Review and update SOPs and procedures for the QC Group as needed.
  • Develop and validate microbiological test procedures for purified water systems, APIs, excipients, finished dosage forms, stability, and AR&D samples.
  • Evaluate potential candidates for QC and conduct performance evaluations of direct reports.

Requirements

  • BS in a scientific discipline or equivalent with 7+ years' relevant experience required.
  • 2+ years' in a lead and/or senior level role in a Quality Microbiology lab.
  • Familiarity with Drug GMP regulations.
  • Strong knowledge of Microbiology and expanded knowledge of Pharmaceutical Microbiology.
  • Knowledge of, and stays current with, regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing.
  • Proficient with laboratory computer software used for stability.
  • Competency in Microsoft Office Suite.
  • General Laboratory safety, including Biohazard safety.

Working at Endo

At Endo, 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.

Equal Employment Opportunity

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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