Senior Manager, QC - Microbiology

Bora Pharmaceuticals
Rockville, MD
Job Description
Role Overview

The Sr. Manager of Quality Control - Microbiology is responsible for leading and ensuring the success of QC-microbiology function and assisting with annual operational planning pertaining to the function.

What You Will Do

Manage a team of QC professionals, direct daily operations of the environmental monitoring and utility monitoring programs, and develop, transfer, and validate microbial test methods.

Why It Might Be a Fit

This person will interact extensively with other department supervisors, Quality personnel, Manufacturing personnel, other business partners, and external clients and sponsors.

Requirements

  • Bachelor’s Degree in a scientific discipline
  • minimum of 7 years of QC Microbiology cleanroom experience
  • At least 2 years of prior experience supervising staff focused on managing performance and productivity
  • Significant knowledge of, and experience with Quality Control processes, working in a GMP testing environment, and Microbiological method validation
  • Familiarity with current EU GMP Annex 1 and contamination control strategy expectations and data integrity (ALCOA+) requirements
  • Significant experience conducting laboratory and environmental excursion investigations
  • Experience with microbial identification
  • Ability to act independently to determine schedules, methods and procedures on new assignments
  • Excellent written and verbal communication skills

Benefits

  • Competitive salary
  • Performance-based incentives
  • Comprehensive health coverage including medical, dental, and vision insurance
  • Retirement savings plans with employer matching contributions
  • Paid time off
  • Professional development opportunities
  • Employee wellness programs and resources
  • Employee Assistance Program and Mental Health Resources
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