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QC Manager, Environmental Monitoring and Microbiology at Serán BioScience
Serán BioScienceBend, Oregon·3w ago
ManagerFull-timeGoAI
About the Role
We are seeking a Quality Control Manager for EM and Microbiology to join Serán BioScience. This role is responsible for developing, executing, and maintaining the environmental monitoring program in compliance with US-FDA, EU, and other applicable regulations. The position requires strong regulatory knowledge and experience in a pharmaceutical manufacturing environment.
Key Responsibilities
- →Ensure EM and Microbiology systems are developed and implemented according to GMP requirements
- →Represent the site in client interactions, audits, and inspections related to microbiology testing and environmental monitoring
- →Oversee daily workflow and supervise microbiology assay and EM teams
- →Review testing and laboratory records for accuracy and compliance with cGMP and company policies
- →Develop site environmental and utility monitoring programs and policies
- →Host monthly trend meetings and drive corrective and preventative actions
- →Lead environmental excursion investigations and monitor resource capacity
- →Build and improve quality systems, control deviations, and oversee CAPA plans
- →Monitor and report OOS/OOT results and prepare for internal audits
Requirements
- ✓BS in related scientific field or equivalent work experience
- ✓Minimum 8 years of Quality Control/GMP/EM/Microbiology experience
- ✓Minimum 3 years of experience in a lead or supervisory position
- ✓Comprehensive knowledge of quality systems, cGMP, and regulatory standards
- ✓Understanding of aseptic processing, environmental monitoring, clean room qualification, and microbiological testing
- ✓Excellent verbal and written communication skills
- ✓Strong supervisory, leadership, and analytical problem-solving skills
- ✓Proficient with Microsoft Office Suite
- ✓Ability to function well in a high-paced environment and meet deadlines
Benefits
- ★Generous PTO accrual (over four weeks annually)
- ★Low-cost health benefits with minimal employee contributions
- ★5% 401(k) contribution without employee match or vesting
- ★Basic life insurance and long-term disability coverage
- ★Employee Assistance Program and access to pet insurance
