Supervisor, Spore Production
$79,687–$103,125 year
On-site · Mentor, Ohio, United States
Job Summary
Spore Production Supervisor oversees daily operations of the Spore Production laboratory at the Pinecone Biological Operations facility, ensuring spore propagation, testing, and preparation comply with regulatory standards (ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR). Responsibilities include leading Quality staff to ensure aseptic, scientific technique per AAMI/ISO/FDA/USP guidelines, managing spore crop disposition and genetic ID, preparing spore suspensions for inoculation, documenting activities for the Device History Record (DHR), maintaining robust production controls aligned with Lean strategies, setting team objectives to meet Quality strategy, and leading talent development. Preferred familiarity with ASQ, QSR, or QSR/GMP regulations. Essential communication, data analysis, problem-solving, and change-management skills are highlighted, along with a strong customer-focused mindset and teamwork. The role requires a Bachelor’s degree (or equivalent experience) and significant experience in regulated production quality, with a leadership component.
Required Qualifications
- Bachelor’s degree or 16 years with HS diploma, or 12 years with Associate’s Degree, or 4 years with an advanced degree
- 6 years of production Quality and/or Quality Management Systems experience
- 4 years of experience in healthcare, medical device, or other regulated industry
- 2 years of experience leading a team and/or supervising employees
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