QC Microbiology Specialist II
About The Position
The QC Microbiology Specialist II performs complex microbiology testing and supports laboratory operations in a cGMP environment. The role guides colleagues in routine testing, conducts qualification and study-directed testing, reviews advanced testing results, and serves as a qualified trainer and subject matter expert for multiple tests. The specialist authors and reviews documents and study protocols, supports investigations, audits, and inspections, and helps ensure compliance with cGMP requirements. The position also supports laboratory management, mentors team members, leads laboratory projects and audit-readiness activities, and applies LEAN and Six Sigma principles to improve laboratory processes. The role requires strong organization, prioritization, analytical, communication, and computer skills; the ability to work varied hours to meet production schedules; and the capacity to work independently in a complex environment with competing demands. The work involves laboratory duties and handling hazardous materials. Employees may need to stand or sit for prolonged periods, walk and drive between locations, wear laboratory protective gowning and equipment, pass an eye exam, and occasionally lift or move up to 50 pounds. Reasonable accommodations may be made for essential functions.
Requirements
- High school diploma, GED, or equivalent credential required.
- 7–9 years of experience in a cGMP environment; an equivalent combination of education and experience will be considered.
- Exceptional organizational skills and attention to detail.
- Ability to plan and prioritize complex activities to meet goals and objectives.
- Strong analytical skills to identify risks and prepare balanced decisions.
- Ability to work varied hours as required by the production schedule.
- People management skills.
- Professional verbal communication skills.
- Solid computer skills.
- Working or theoretical knowledge of laboratory equipment.
- Ability to identify process improvements.
- Ability to follow written instructions and independently troubleshoot common issues, and provide expertise in responding to complex issues.
- Ability to work in a highly complex environment with competing demands and priorities.
- Ability to perform essential job functions involving prolonged sitting or standing, walking and driving between locations, wearing laboratory protective gowning and equipment, occasional lifting or moving of up to 50 pounds, passing an eye exam, and working with or handling hazardous materials.
Nice To Haves
- Associate or bachelor’s degree in microbiology or a related scientific field preferred.
Responsibilities
- Perform non-routine, complex testing; identify requirements and execute actions as part of the change control process.
- Assist and guide others in the laboratory with routine testing.
- Perform high-throughput, right-first-time work to meet production schedules and project milestones with minimal or no supervision.
- Lead qualification and study-directed testing activities.
- Review and evaluate advanced laboratory testing results.
- Serve as a qualified trainer and subject matter expert for multiple tests.
- Author, review, and edit documents and study protocols.
- Support intermediate investigations of out-of-specification (OOS) assays and events.
- Ensure compliance with cGMP and participate in audits and inspections.
- Support laboratory management and mentor team members as needed.
- Lead LEAN laboratory and Six Sigma principles and apply them to laboratory processes.
- Act as project leader for laboratory and departmental projects.
- Lead audit readiness and participate in or support audit activities for the team.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
