Supervisor, Spore Production

The Spore Production Supervisor is responsible for overseeing daily operations of the Spore Production laboratory at the Pinecone Biological Operations facility. This role combines hands-on microbiological production expertise with leadership responsibilities, ensuring that spore propagation, testing, and preparation activities are performed in compliance with regulatory requirements including ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standard and internal quality standards.

This position is responsible for all aspects of spore production within the organization including ensuring adherence to aseptic practices and written procedures and supports continuous improvement initiatives while maintaining production timelines and product quality for Biological Indicators. This position develops and manages work assignments, analyzes, and trends Quality performance data and utilizes problem solving methods to improve processes and eliminate Quality issues.

• Lead and manage assigned Quality staff to ensure aseptic, scientific technique following the guidelines of AAMI, ISO, FDA and the USP in accordance with facility procedures.
• Lead and manage disposition of spore crops according to microbiological tests including gram-staining, morphological characterization, spore crop titer, purity, and genetic ID via third party.
• Lead and manage preparation of spore suspensions for inoculation on specified carrier material in accordance with product specifications, reworking of spore suspension spore titers, and testing of the spore suspension, media, carrier material, and packaging materials as needed to meet specifications for release to production.
• Lead and manage team documention of spore production activities to complete the Device History Record (DHR) and accurately reviews those from other staff.
• Ensure robust production and process controls that are in alignment with production and Lean strategies.
• Establish individual and team objectives to attain key metric performance and ensure alignment to the overall Quality strategy.
• Lead the Team's talent development processes and knowledge development.
• Assume other duties as assigned.

Required:

• 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.
• 4years of experience in healthcare, medical device, or other regulated industry.
• 2 years of experience leading a team and/or supervising employees.

Preferred:

• ASQ, QSR, or familiarity with QSR/GMP regulations.

Other:

• Customer Focused: Demonstrates a "Customer first" mindset. Responds with a sense of urgency.
• Teamwork: Collaborates with others. Works in a professional manner to support team actions.
• Results: Effectively manages work tasks. Is detail oriented and strives for continuous improvement. Ability to analyze technical issues. Ability to cope with change and shifting priorities.
• Communication: Constructs clear written communication. Keeps manager and co-workers informed.
• Job Knowledge: PC experience and working familiarity of common desktop applications including Excel and Word.
• Initiative/Leadership: Takes ownership of task and projects and seeks clarification if unsure of direction.
• Ability to analyze and interpret data; utilize problem solving methodologies and drive process improvements.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is a brief overview of what we offer:

• Market competitive pay
• Extensive paid time off and (9) added holidays
• Excellent healthcare, dental, and vision benefits
• Long/short term disability coverage
• 401(K) with company match
• Maternity and parental leave
• Additional add on benefits/discounts for programs such as pet insurance
• Tuition reimbursement and continued educational programs
• Excellent opportunities for advancement in a stable long-term career

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