Manager, QC Microbiology

Overview
Responsible for maintaining quality standards for our pharmaceutical and device products by leading and managing day-to-day activities for the Microbiology group. This includes ownership of the Environmental Monitoring program as well as the in-process and release testing of raw materials and drug products. Provides QC microbiological guidance and support throughout the company
Responsibilities

• Provide leadership in the QC organization to ensure compliance, drive improvements and achieve schedule adherence.
• Establish internal QC Microbiology lab to perform EM viable and non-viable monitoring, purified water testing. Ensure that EM data is trended quarterly and annually and manage EM Excursions.
• Support all programs (clinical and commercial) with Endotoxin and Bioburden testing in compliance with the compendial requirements.
• Manage the testing of clinical and commercial products performed at outside testing laboratories.
• Ensure that all microbiology tests are appropriately qualified/validated for the components and/or drug product formulations
• Lead/manage Deviations, CAPAs, Out-of-Specification (OOS) and out of tolerance (OOT) investigations for product and Environmental Testing.
• Maintains staff by recruiting, selecting, and training
• Cross train all microbiology personnel in all aspects of Environmental Testing, Bioburden and Endotoxin testing
• Review departmental documentation (e.g., standard operating procedures, results, deviation and CAPAs). Lead and manage revisions, accepting cross-functional input, as necessary.
• Participates in internal and external audits as
• Follow Good Documentation Practices (maintaining contemporaneous records, filling out logbooks, forms, etc.)

Qualifications

• Bachelor's Degree in Life Sciences; Microbiology preferred
• 8+ years' experience in the pharmaceutical industry with prior supervisory experience
• Operation in a GMP setting to include use of Good Documentation
• Familiarity with clean room operational procedures, including gowning, cleaning, certification, and monitoring
• Knowledge of CFR 210, 211, USP, and FDA/ICH guidance
• Experience with external regulatory inspections (e.g., FDA)
• Excellent organizational skills and attention to detail
• Strong interpersonal, verbal, and written communication skills
• Computer literacy, proficiency in MS Office, Excel, PowerPoint,
• Knowledge of safe laboratory practices

Job Summary

• Job ID: 2023-1652
• # of Openings: 1
• Category: Quality