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Job Title: Regional Quality Assurance Manager
Reporting To: Vice President of Biotech Operations
Location: Madisonville, TX - provides quality oversight for Madisonville, TX & San Juan Bautista, CA
Our simple vision is to be the best integrated mushroom company in North America by efficiently delivering superior value to our customers and consumers. We do that by creating long-term value for customers, teammates, suppliers, and the communities in which we operate. We work intentionally toward that vision with a collaborative team foundation. Our principles of trust, respect, integrity, shared vision, empowerment, teamwork, accountability, and continuous improvement spur our actions every day as we work to achieve our purpose.
At the heart of our culture is a group of individuals who dedicate themselves to their work and each other day in and day out. That's why we invest in enhancing the lives in the communities around Monterey Mushrooms locations. In our hearts, we're humble farmers. We're proud of our continent-wide reach from Monterey Mushrooms locations across North America - from coast to coast and Mexico - focused on our company purpose of Enhancing People's Lives. For more information, please visit our website. www.montereymushrooms.com.
Amycel Spawn Mate is the industry leader in mushroom genetics and spawn development that supports the gourmet, medicinal, and exotic mushroom markets around the world. Amycel Spawn Mate has been serving the Mushroom Industry in North and South America since the late 1970s, and internationally since the early 1990s. Amycel Spawn Mate is the company you can depend on to help you grow the best. For increased productivity, the consistency you need and the quality you demand, Amycel Spawn Mate delivers. We provide mushroom spawns, supplements, and services that mushroom growers need worldwide. We are the world leader in mushroom strain development. Over 90% of North American growers use our two proprietary brown mushroom spawn. Our Research and Development Group creates the best strains for all growing environments, and it is hard at work developing a new hybrid strain of white mushroom spawn. Visit us at www.Amycel.com.
Monterey Nutraceuticals is the current medicinal mushroom industry split between low-quality producers and US cultivators with limited capabilities and product offerings. The industry is void of a low-cost, US-based producer that can offer a full medicinal mushroom product line (pure fruiting body and mycelium-based products) and that can serve as an unbiased, scientifically sound market educator and leader. As the industry leader for over 50 years, Monterey Mushrooms has the production capacity, expertise, distribution network, R & D capability, and trusted brand to fill the market void and become the dominant global supplier of US-grown medicinal mushrooms. We know mushrooms! From seed (spawn) to powder, we have control over every aspect of our business as we're a vertically integrated mushroom producer in North America. The spawn we use to grow our medicinal mushrooms is produced by our affiliate, Amycel SpawnMate. Then, we grow, dry, and package everything at our facilities in California to ensure our mushroom powders reach their full potential. If that is not enough, we third-party test for heavy metals, pesticides, mycotoxins, polysaccharides, and various compounds. In house, we test every product for potency, quality, and purity, and we have that verified by a third party periodically. Monterey Nutraceuticals is a portfolio company of Paine Schwarz Partners, who invested in the business in May 2022. For more information, visit us www.montereymushrooms.com/nutraceuticals.
Why This Role Matters
The Regional Quality Assurance Manager will direct the Quality Assurance and food-safety programs for Amycel's spawn and Spawn Mate supplement production, providing quality oversight for both the Madisonville, TX and San Juan Bautista, CA, and New Albany, IN facilities. This leadership position stands up and matures a robust sanitation and environmental-monitoring program, drives disciplined root cause analysis, and builds a closed-loop continuous-improvement system that steadily reduces product contamination, product defects, and process defects. The role provides effective communication across all levels of the organization, develops and trains staff, leads Quality process-improvement projects, and works with Corporate Quality Assurance on continuous-improvement initiatives. Based in Madisonville with occasional travel to San Juan Bautista and other network sites; occasional nights, weekends, and coverage beyond normal hours may be required.
Essential Duties and Responsibilities:
• Direct, develop, and maintain the facility's quality system in compliance with the Corporate Quality Policy, ensuring the safety, purity, and quality of all raw materials, cultures, inoculum, and finished spawn and supplement products.
• Maintain and strengthen the sites' current food-safety and compliance programs - including PrimusGFS (San Juan Bautista) and organic (CCOF/OMRI) certification - and lead the roadmap toward GFSI certification as the program matures. Support kosher requirements where applicable to specific products.
• Develop, lead, and validate robust plant GMP, hygiene, and sanitation programs across all shifts, including a master sanitation schedule that meets or exceeds regulatory and company standards.
• Build and lead a comprehensive environmental monitoring program (air, surface, water, and personnel) to detect and control contaminants such as bacteria and wild/competitor molds; manage cleanroom, laminar-flow, HEPA, and positive-pressure controls and enforce aseptic technique and gowning.
• Establish and validate control points for media preparation, substrate/grain sterilization (autoclave cycles, biological indicators), inoculation, and incubation - applying HACCP like principles judiciously to focus controls where risk is greatest and avoid unnecessary record-keeping burden.
• Lead pest and vector control relevant to grain-based spawn (including mites and flies that can vector contamination) and manage foreign-material and allergen controls.
• Lead root cause analysis investigations for deviations, hot spots, and elevated results, ensuring corrective and preventive actions (CAPA) are fully implemented and verified for effectiveness and that organisms are not reintroduced into the environment.
• Lead the customer complaint resolution process; investigate and drive the corrective actions needed to mitigate quality problems and respond to specific customer quality concerns.
• Serve as the primary contact for regulatory bodies, customers, and third-party auditors; develop and facilitate internal audits of raw materials, packaging components, suppliers, and warehousing procedures; make customer/market visits as required.
• Manage the QA document-control and food-safety records system in partnership with the culture/R&D team, who retain ownership of culture operations and master production SOPs.
• Design and execute closed-loop programs using KPIs and metrics to drive continuous improvement in product quality, process efficiency, and waste reduction; drive measurable reductions in product contamination, product defects, and process defects.
• Advise the Plant Management Team on quality trends; provide technical support for process instructions, formulas, and product specifications; maintain instrument calibration and data integrity.
• Prepare and manage the annual operating budget for the Quality Assurance department; own the site quality KPIs and contribute directly to facility and division P&L accountability.
What's The Right Fit

• Bachelor of Science in Food Science, Ag Science, Microbiology, Biology, or a related discipline (or 10+ years of direct equivalent experience).
• Seven or more years of plant or corporate quality assurance experience, including operations management.
• HACCP or PCQI certified; experience designing and implementing HACCP programs.
• Experience maintaining audited food-safety and organic programs (e.g., PrimusGFS, CCOF/OMRI).
• Proficiency in Microsoft Word, Excel, PowerPoint, and Office 365 programs.

The Leader We're Looking For

• Working knowledge of microbiology, aseptic technique, environmental monitoring, and sanitation chemistry.
• Strong command of root cause analysis and continuous-improvement tools (5-Why, Fishbone, FMEA, Pareto, CAPA).
• Strong systems thinking with KPI-driven improvement and a hands-on management style.
• Excellent project management and organizational skills; able to develop a plan of action from a concept and carry it through to completion.
• Ability to develop and manage a department budget, monitor spending, and prioritize resources.
• Ability to interface across all levels of the organization and to work under pressure and tight deadlines with humor and grace.
• Highly proficient in Microsoft Word, Excel, PowerPoint, and Office 365 programs.