Quality Control Specialist, Microbiology

• Lead microbial identification activities, organism assessments, and support routine and non-routine microbiological testing
• Provide leadership for microbiology laboratory operations, coordinate daily priorities, supervise laboratory staff, and support weekend laboratory operations
• Own and lead complex microbiological investigations, deviations, environmental monitoring excursions, and contamination events, including root cause analysis, risk assessments, and product impact assessments
• Provide technical expertise for environmental monitoring, bioburden control, microbial identification, contamination control strategies, and laboratory controls
• Author and drive CAPAs, microbial risk assessments, and change controls to ensure compliant resolution of quality events
• Coordinate contract laboratory activities, including testing support, data review, investigation collaboration, and approval of associated documentation
• Generate and maintain complete, accurate, and inspection-ready documentation using electronic laboratory and quality systems (e.g., LMES, LIMS, CIMS, and Veeva)
• Partner with Quality, Manufacturing, Engineering, and global microbiology teams to support process improvements, operational excellence initiatives, regulatory inspections, and strategic microbiology projects

High school diploma / GED and 10 years of Quality, Microbiology or Operations experience OR Associate’s degree and 8 years of Quality, Microbiology or Operations experience OR Bachelor’s degree and 4 years of Quality, Microbiology or Operations experience OR Master’s degree and 2 years of Quality, Microbiology or Operations experience OR Doctorate degree

• Microbiology degree and/or microbiology laboratory experience associated with microbial identification
• Demonstrated leadership experience, including coaching and developing staff, prioritizing laboratory workloads, and supporting routine and non-routine microbiological testing
• Understanding of manufacturing processes associated with contamination control
• Experience supporting regulatory inspections and audit readiness activities
• Advanced technical writer who can articulate complex events into concise, clear, and contemporaneous documentation that is inspection ready
• Professional work experience in a fast-paced, flexible GMP laboratory
• Ability to generate, investigate, triage and close deviations and analytical test result assessments in Veeva
• Ability to generate and document validation protocols and reports
• Experience performing aliquoting of samples aseptically
• Operation, maintenance experience with laboratory equipment
• Ability to generate and revise methods and SOPs within CDOCs
• Demonstrated proficiency with electronic systems capturing consumables, testing procedures, results, and investigations (SAP, LIMS, LMES, CIMS, Veeva, etc.)
• Demonstrated understanding and use of Maximo (Work Order System)
• Ability to manage and lead Operational Excellence initiatives including 5S and Standard Work associated with the testing labs
• Demonstrated written and oral communication skills, project management and presentation skills, and proven ability to manage priorities effectively
• Demonstrated ability to be flexible and adaptable to support business needs

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible