Quality & Bioprocess Analytics Manager

At Holganix, we revolutionize the way the world grows by manufacturing and distributing a liquid microbial solution (think of it as a probiotic for soil) to primarily farmers (but also landscapers, golf courses, and performance turf users) across America and Canada. Our solution dramatically increases soil health, ultimately improving crop yield and reducing the need for other inputs like fertilizer, pesticides, and water. Additionally, our solution significantly impacts carbon sequestration in the soil and improves the carbon intensity score of a crop.

The Quality Assurance Manager will play a significant role in the quality assurance and quality control activities at Holganix’s Blue River production facility in Kansas City, MO. Working collaboratively with company and facility leadership, production, scientific, and other quality stakeholders, this position will help lead the establishment, implementation, execution, and ongoing maintenance of quality practices that support consistent batch production, raw-material control, microbiological testing, traceability, and reliable product quality at the Blue River facility and other Holganix facilities.

The role will be an important contributor to development and execution of the site Quality Management System (QMS) and to building the quality culture, documentation practices, and systems needed to support future ISO 9001 accreditation. This is a hands-on position: the Quality Assurance Manager must be comfortable working on the laboratory bench and performing routine microbiology-based QC activities, while primarily helping ensure that QA/QC systems are established, documented, followed, maintained, and continuously improved.

Success in this role requires a combination of strong quantitative analytical skills, an understanding of biological systems, and the ability to collaborate across scientific and operational teams.

Responsibilities

• Lead and significantly contribute to the development, implementation, maintenance, and continuous improvement of the site Quality Management System (QMS), including establishing and maintaining controlled quality procedures, SOPs, work instructions, forms, specifications, and records, with practices designed to support future ISO 9001 accreditation.
• Ensure batch-to-batch quality control practices are consistently executed, reviewed, documented, and followed across fermentation and biological production activities.
• Partner with production and laboratory teams to establish and maintain sampling plans, in-process controls, acceptance criteria, release specifications, and QC testing for raw materials, fermentation processes, intermediates, and finished products.
• Oversee raw-material quality controls, including receipt, identification, status, sampling, testing, disposition, traceability, supplier documentation, and review/approval of Certificates of Analysis (COAs).
• Review batch records and associated QC data for completeness, accuracy, procedural compliance, and conformance to specifications; identify and resolve quality or documentation gaps prior to disposition.
• Maintain and oversee quality-system processes for deviations/nonconformances, investigations, CAPA, change control, effectiveness checks, internal audits, and corrective-action follow-through.
• Maintain quality records and controls for equipment qualification, calibration, preventative maintenance, service and status, as well as training and competency documentation for quality-critical procedures.
• Analyze quality trends and batch-to-batch performance to identify recurring issues, process variability, preventative actions, and opportunities for continuous improvement.
• Lead and support supplier qualification and monitoring, external audit readiness, gap assessments, and future ISO 9001 accreditation activities.
• Perform and/or coordinate microbiology-based QC testing and other laboratory activities using approved methods and good documentation practices.
• Collaborate with facility leadership, production, laboratory, and R&D teams to integrate quality requirements into daily operations and promote a strong quality culture and safe working practices.
• Serve in a player/coach capacity, balancing hands-on laboratory and QC responsibilities with a significant role in shaping the facility’s quality systems and practices. The position will actively perform and support routine QC activities while also serving as a quality thought leader – helping establish, implement, and continuously improve the processes, procedures, documentation, and systems required to ensure consistent product quality and support the facility’s evolving Quality Management System.

Requirements

• B.S. in Microbiology, Biology, Biotechnology, Biochemistry, Food Science, Fermentation Science, or a closely related life-science discipline; advanced degree is a plus.
• At least 7+ years of experience in quality assurance and/or quality control in a laboratory, fermentation, biotechnology, biological manufacturing, food, agricultural biologicals, or related production environment.
• Demonstrated experience working within a formal Quality Management System; experience in an ISO 9001-accredited or ISO 9001-aligned environment is strongly preferred.
• Experience with document control, SOP management, batch records, deviations/nonconformances, CAPA, change control, internal audits, training records, equipment calibration/maintenance records, and controlled quality documentation.
• Expert knowledge of microbiology laboratory methods used for routine QC, such as aseptic technique, culture-based testing, plate counts, microscopy, pH measurement, and other basic analytical or microbiological methods relevant to batch production.
• Experience reviewing raw-material quality documentation, including Certificates of Analysis, specifications, lot traceability, and supplier documentation.
• Ability to work effectively at the laboratory bench while also managing quality systems, resources, documentation, investigations, and cross-functional quality activities.
• Strong problem-solving and root-cause analysis skills with the ability to make practical, scientifically sound quality decisions.
• Exceptional attention to detail, organization, data integrity, and documentation quality.
• Strong written and verbal communication skills, including the ability to write clear SOPs, quality records, investigation summaries, and training materials.
• Ability to play a leadership role in quality initiatives within a new and evolving facility, help establish systems where they do not yet exist, and influence personnel across functions without relying on direct authority.
• Ability to travel to other Holganix locations as required.

Preferred:

• Proficiency with Microsoft Word and Excel; experience with electronic document-control, QMS, LIMS, or related quality software is preferred.
• Familiarity with fermentation, microbiology, or biological manufacturing preferred.

Physical Requirements:

• Ability to work on-site in laboratory and production environments and move between office, laboratory, fermentation, and manufacturing areas throughout the workday.
• Ability to stand for extended periods and perform routine laboratory activities, including pipetting, plating, sample preparation, and use of standard microbiology and QC equipment.
• Ability to lift and carry laboratory or production materials up to approximately 25-40 lbs.
• Ability to safely use standard laboratory equipment such as pipettes, balances, incubators, centrifuges, pH meters, and related QC instrumentation.
• Comfortable working around fermentation operations and biological materials while following applicable biosafety, sanitation, and facility procedures.
• Willingness to wear required PPE, including gloves, lab coat or protective clothing, eye protection, and other facility-specific PPE.