Quality & Bioprocess Analytics Manager

Holganix•Blue River, CO

5d•Onsite

About The Position

The Quality & Bioprocess Analytics Manager will support quality assurance and quality control activities at Holganix’s Blue River production facility in Kansas City, Missouri, working with company and facility leadership, production, scientific, and quality stakeholders. The role helps establish, implement, execute, maintain, and continuously improve 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 position contributes to developing and executing the site Quality Management System (QMS), building quality culture and documentation practices, and establishing systems to support future ISO 9001 accreditation. It is a hands-on player/coach role that combines routine bench-level microbiology and QC work with significant responsibility for establishing, documenting, maintaining, and improving quality systems. Success requires quantitative analytical skills, understanding of biological systems, and collaboration across scientific and operational teams.

Requirements

Bachelor’s degree in Microbiology, Biology, Biotechnology, Biochemistry, Food Science, Fermentation Science, or a closely related life-science discipline; an 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 with document control, SOP management, batch records, deviations and nonconformances, CAPA, change control, internal audits, training records, equipment calibration and maintenance records, and controlled quality documentation.
Expert knowledge of routine microbiology laboratory methods for QC, such as aseptic technique, culture-based testing, plate counts, microscopy, pH measurement, and other relevant basic analytical or microbiological methods.
Experience reviewing raw-material quality documentation, including Certificates of Analysis, specifications, lot traceability, and supplier documentation.
Ability to work at the laboratory bench while 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 lead quality initiatives in a new and evolving facility, 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.
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 weighing approximately 25–40 pounds.
Ability to safely use standard laboratory equipment such as pipettes, balances, incubators, centrifuges, pH meters, and related QC instrumentation.
Comfort 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.

Nice To Haves

Experience in an ISO 9001-accredited or ISO 9001-aligned environment is strongly preferred.
Proficiency with Microsoft Word and Excel.
Experience with electronic document-control, QMS, LIMS, or related quality software.
Familiarity with fermentation, microbiology, or biological manufacturing.
An advanced degree in a relevant discipline.

Responsibilities

Lead and contribute to development, implementation, maintenance, and continuous improvement of the site QMS, including controlled procedures, SOPs, work instructions, forms, specifications, and records designed to support future ISO 9001 accreditation.
Ensure consistent execution, review, documentation, and compliance with batch-to-batch quality control practices across fermentation and biological production activities.
Work 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 or approval of Certificates of Analysis.
Review batch records and related QC data for completeness, accuracy, procedural compliance, and conformance to specifications; identify and resolve quality or documentation gaps before disposition.
Maintain quality-system processes for deviations and nonconformances, investigations, CAPA, change control, effectiveness checks, internal audits, and corrective-action follow-through.
Maintain quality records and controls for equipment qualification, calibration, preventive maintenance, service and status, and training and competency documentation for quality-critical procedures.
Analyze quality trends and batch-to-batch performance to identify recurring issues, process variability, preventive actions, and continuous-improvement opportunities.
Lead and support supplier qualification and monitoring, external audit readiness, gap assessments, and future ISO 9001 accreditation activities.
Perform 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.
Balance hands-on laboratory and QC responsibilities with shaping facility quality systems and practices, actively supporting routine QC activities and helping establish and improve processes, procedures, documentation, and systems for consistent product quality.