Quality Control Supervisor (Microbiology)

Scismic is supporting the growth of an early-stage contract research organization (CRO) that has been in the business for over 75 years with over 20,000 employees and 110 facilities in over 20 countries around the world.

Job Summary

Quality Control Microbiology Supervisor requires working knowledge of Environmental Monitoring of Good Manufacturing Practices (GMP) cleanrooms including how to appropriately and effectively complete investigations of excursions. Familiarity with compendial microbiological testing methods for sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.), is essential.

• Reviews and maintains documentation and records for accuracy and compliance
• Utilize common problem-solving tools and methodologies in processes and procedures for root cause analysis and resolution
• Prepare for and actively participate in internal and external audits, investigations, and reporting
• Prepares and facilitates reporting, as requested by QC Micro Leadership Team
• Ensure timely response and closure of customer complaints
• Leads all activities associated with daily operations of the QC Micro Department
• Conducts and leads meetings and communications effectively
• Review and approve QC Micro data for accuracy and compliance to applicable SOPs and Test Methods
• Manages KPI performance, goals, and objectives
• Oversee the performance of QC Analyst providing support and guidance by coaching areas of growth and development and recognizing and rewarding successes
• Provide direction and technical expertise to Micro team
• Seek to understand and operate within the department budget, cost and profitability restraints, and ensure that materials meet regulatory requirements
• Issues and traces necessary deviations, change controls, CAPAs, related to QC Micro Department

Job Qualifications

• Ability to supervise and manage the schedule of Analysts
• 3-4 years of relevant Microbiology experience preferred or equivalent combination of education and experience
• Bachelor's degree in biology or relevant scientific discipline
• Experience performing and managing performance of Environmental Monitoring of GMP cleanrooms.

Additional Info:

• Relocation assistance provided
• Will sponsor H1B

Job Type: Full-time

Pay: $70,000.00 - $85,000.00 per year

Schedule:

• Monday to Friday
• Day shift

Work Location: In person