Quality Assurance Manager - Dietary Supplements

Position Summary

The Quality Assurance (QA) team is committed to upholding high standards of quality and compliance through established procedures and rigorous testing. This role is crucial in developing, managing, monitoring, and coordinating quality control and assurance programs for dietary supplement manufacturing processes, ensuring adherence to cGMP regulations and other applicable federal and state regulatory requirements.

This is a full-time, exempt position with standard business hours from Monday to Friday, 8:00 a.m. to 4:30 p.m. Occasional work outside these hours may be required. The position is based in Tumwater, WA, and involves travel to different business locations; occasional remote work is available. The Manager of Quality Assurance supervises two full-time staff members and reports directly to the President & Chief Operations Officer.

Essential Duties & Responsibilities

• Develop and maintain quality systems aligned with 21 CFR Part 111 cGMP requirements for dietary supplements and 21 CFR Part 117 cGMP requirements for hazard analysis and risk-based preventative controls for human food.
• Foster internal communication on quality issues throughout the organization.
• Independently detect quality problems and implement effective solutions.
• Ensure compliance with cGMP regulations related to dietary supplement identity, purity, strength, and composition.
• Establish, maintain, and monitor procedures for operational and quality system activities, including specifications, master manufacturing records, plans, and documentation.
• Implement, maintain, monitor, and report cleaning and sanitation programs for dietary supplement products according to GMP requirements.
• Periodically evaluate quality systems and identify opportunities for improvement.
• Maintain positive working relationships with department heads to support compliance activities.
• Implement and assist in 21 CFR Part 111 cGMP training for designated employees.
• Coordinate with manufacturers to ensure all regulatory requirements and documentation are met.
• Provide a controlled process for approval and release of controlled documents, maintaining document integrity, security, and accessibility.
• Act as the main point of contact for audits performed by third parties of company facilities, contract manufacturers, suppliers, and other vendors.
• Develop, review, and approve consumer complaint reports, ensuring all complaints are appropriately investigated and reported.
• Ensure proper documentation, evaluation, and reporting of life-threatening, serious, and unexpected adverse events or reactions associated with dietary supplement products.
• Implement, monitor, and maintain inspection systems to ensure dietary supplement products are produced in compliance with internal procedures, established specifications, and GMP requirements.
• Ensure implementation and maintenance of pest control programs and work with department leadership to design/revise programs to prevent product contamination.
• Coordinate activities surrounding regulatory inspections.
• Initiate, develop, and execute Quality Agreements with contractors to define and implement quality-related roles and responsibilities.
• Assist in identifying, developing, and executing processes to reduce the risk of intentional harm associated with dietary supplement products.
• Ensure packaging revisions are compliant with applicable regulations and implement checks and inspections to ensure packaging is designed and printed with approved content.
• Participate in the development of product specifications.
• Review all marketing, education, print, and digital materials intended for consumer or industry distribution to ensure Dietary Supplement Health and Education Act (DSHEA) compliance.
• Supervise assigned staff, hire, evaluate, train, and implement corrective action as necessary.
• Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control.
• Provide training to employees or oversee the deployment of training through department members.
• May serve as the quality representative on cross-functional teams.
• Perform a variety of other administrative duties as assigned.
  
  

Preferred Qualifications

• Bachelor's Degree in Quality Assurance or Control, Manufacturing Management, or a closely related field of study from an accredited institution of higher education. A combination of relevant experience and education may be considered in lieu of a four-year degree.
• Five (5) years of professional experience in quality assurance/control; three (3) or more years' experience leading quality assurance/control is required.
• Demonstrated track record of managing hands-on cGMP manufacturing operations.
• Experience with analytical methodologies and establishing product specifications.
• Preferred experience with NSF, ANSI, and/or SQF.
• Experience and thorough understanding of coordinating manufacturing activities with other departments (QA, QC) to maintain internal and project schedules.
• Creative individual with excellent troubleshooting skills related to scientific and engineering principles.
• Solid technical understanding of GMP biologics manufacturing processes and equipment.
• Ability to work both independently and collaboratively with scientific and engineering staff across multiple disciplines in a fast-paced and dynamic environment.
• Exceptional focus on quality and attention to detail.
• Possession of, or ability to obtain a driver's license acceptable for use in the state of Washington.
  
  

Knowledge, Skills & Abilities

• Ability to juggle multiple projects, adjust priorities as needed, and shift gears in a fast-paced business environment.
• Ability to communicate effectively in writing as appropriate for the needs of the audience.
• Ability to communicate at all levels within and outside of the organization while living the company values.
• Ability to bring others together and reconcile differences.
• Ability to act with high moral standards and integrity.
• Skill in applying complex analytics and conceptual thinking skills to develop and evaluate options and implement solutions.
• Demonstrated ability to perform quality control analytics through tests and inspections of products, services, or processes to evaluate quality or performance.
• Knowledge of business and management principles involved in strategic planning, resource allocation, leadership techniques, production methods, and coordination of people and resources.
• Ability to operate a personal computer in a networked environment; proficient in Microsoft Office suite. Familiarity with statistical software highly preferred.
  
  

Physical & Mental Requirements

• Ability to lift and carry up to 20 pounds on an infrequent basis.
• Ability to sit for prolonged periods of time; a stand-up desk is available upon request.
• Ability to communicate effectively by expressing oneself clearly and accurately in a business conversation.
• Ability to see details at close range (within a few feet of the observer).
• Ability to arrange things or actions in a certain order or pattern according to a specific rule or set of rules.
• Ability to perceive, recognize, inspect, and assess a variety of work situations in order to analyze and make recommendations.
• Ability to use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
• Ability to concentrate for extended periods of time and apply deductive and inductive reasoning, problem sensitivity, and mathematical reasoning.
• Ability to match or detect differences between colors, including shades of color and brightness. Ability to see details at a distance.
  
  

Salary Range (DOE)

\(100,000 - \)130,000/yr

The pay range for this job is published in compliance with the State of Washington's Equal Pay Opportunities Act and is not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with labor market data, or other applicable law.

We are unable to provide assistance to those seeking authorization to work in the US.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, genetic information, national origin, disability, or veteran status.

Employment Type: Full-Time