QC Manager, Microbiology

Kelly Science, Engineering, Technology & Telecom; United States; Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Kelly Science, Engineering, Technology & Telecom is seeking a QC Microbiology Manager in the United States. This full-time role involves overseeing microbiological operations in a regulated pharmaceutical manufacturing environment, ensuring compliance with GMP and global regulatory standards.

The successful candidate will lead a laboratory team, manage microbiological testing, and drive continuous improvement initiatives. A Bachelor's degree in Microbiology and over 10 years of relevant experience are required. Strong leadership and communication skills are essential for this position.

Qualifikationen

• 10+ years of microbiology laboratory experience in a pharmaceutical manufacturing environment.
• 3+ years of leadership experience managing microbiology operations and personnel.
• Strong knowledge of GMP, FDA, USP, and global regulatory requirements.

Aufgaben

• Lead/manage all QC Microbiology lab operations with a team of 12-15 analysts.
• Oversee microbiological testing for raw materials, in-process samples, and finished products.
• Ensure timely, accurate, and compliant reporting of microbiological test results.

Kenntnisse

Leadership

Communication

Problem-solving

Organizational skills

Ausbildung

Bachelor’s degree in Microbiology or related field

Advanced degree preferred

Tools

LIMS

QMS

Jobbeschreibung

QC Microbiology Manager – Full-Time Direct Hire

Schedule: Monday-Friday 8am-5pm

Seeking an experienced QC Microbiology Manager to oversee microbiological operations within a regulated pharmaceutical manufacturing environment. This leadership role is responsible for ensuring compliance with GMP and global regulatory standards while managing microbiological testing, contamination control programs, laboratory investigations, and daily laboratory operations.

Key Responsibilities:

• Lead and manage all QC Microbiology laboratory operations, including oversight of a team of approximately 12–15 analysts
• Oversee microbiological testing for raw materials, in-process samples, finished products, stability samples, packaging components, and environmental monitoring programs
• Manage testing activities including sterility, bioburden, endotoxin, particulate matter, growth promotion, personnel monitoring, and environmental monitoring
• Ensure timely, accurate, and compliant reporting of microbiological test results and laboratory documentation
• Lead investigations involving deviations, out-of-specification results, environmental excursions, sterility failures, and atypical findings, including root cause analysis and CAPA implementation
• Partner cross-functionally with Manufacturing, Sterility Assurance, Engineering, Validation, and Quality teams to support contamination control strategies and production schedules
• Review and approve SOPs, specifications, validation protocols, test methods, and change controls impacting microbiology operations
• Maintain audit readiness and support internal and external regulatory inspections
• Conduct trend analysis of microbiological and environmental monitoring data to identify potential risks or quality concerns
• Drive continuous improvement initiatives focused on laboratory efficiency, compliance, and method robustness
• Provide technical leadership, mentorship, and training to microbiology staff while ensuring training compliance and competency standards are maintained
• Utilize LIMS and other quality systems to ensure data integrity and regulatory compliance

Qualifications:

• Bachelor’s degree in Microbiology or related scientific discipline (advanced degree preferred)
• 10+ years of microbiology laboratory experience within a regulated pharmaceutical manufacturing environment
• 3+ years of leadership experience managing microbiology operations and laboratory personnel
• Strong knowledge of GMP, FDA, USP, and global regulatory requirements
• Experience supporting aseptic manufacturing, terminal sterilization, contamination control, and environmental monitoring programs
• Proficiency with LIMS, QMS, and laboratory investigation processes
• Strong leadership, communication, organizational, and problem-solving skills