QC Manager, Environmental Monitoring and Microbiology

The Quality Control Manager, EM & Microbiology will be responsible for improving, developing, executing, and maintaining the EM program at Serán BioScience.

Requirements

• Comprehensive knowledge of quality systems, cGMP, regulatory and industry standards at all phases of drug development with prior experience through commercialization
• Proven experience developing budgets, monitoring, and escalating variances
• Experience and/or knowledge of process validation lifecycle approach for biological product is preferred
• Excellent knowledge of FDA/EU/ICH/CDN/AUS guidelines and inspections
• Understanding of aseptic processing, environmental/utility monitoring, clean room qualification, and microbiological testing required
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Accepts feedback from a variety of sources and constructively manages conflict
• Excellent time management skills with a proven ability to meet deadlines
• Strong analytical and problem-solving skills
• Demonstrate integrity towards testing and reporting
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company
• Strong supervisory and leadership skills
• Ability to prioritize tasks and to delegate them when appropriate
• Ability to function well in a high-paced and at times stressful environment
• Proficient with Microsoft Office Suite or related software

Benefits

• Generous Paid Time Off
• 401k Matching
• Basic Life Insurance
• Long-term Disability Insurance
• Employee Assistance Program
• Pet Insurance