Overview The Quality Systems Manager is responsible for all the planned and systematic activities implemented to ensure all our products meet standards for quality, including those defined by customer specifications, government regulations, and company policies. Job Responsibilities Train quality assurance staff Evaluate performance of quality control personnel Oversee the daily workflow of the department, including 2 direct reports Develop, implement, and manage processes and checklists to ensure that products meet required specifications for quality, function, and reliability prior to shipment Establish quality standards, specifications, and parameters per product Coordinate and facilitate product testing processes, internal and external Organizing workflow to meet specifications and deadlines Communicate quality standards and parameters to QC/QA, production, facility, and other appropriate departments Make calls regarding the stop of production to isolate and minimize risk of defect spread Monitor production sheets for accurate entries and correct errors in sheet functionality Review client, customer, and user feedback Maintain compliance with federal, state, local, and organizational laws, regulations, guidelines, and policies, including 21 CFR Part 111 dietary supplement cGMP requirements Oversee Master Manufacturing Records, Batch Production Records, batch record review, and finished-product release Oversee deviations, investigations, CAPA, change control, supplier qualification, and raw-material/component qualification Oversee complaint handling and the stability program Ensure appropriate environmental and production quality controls are maintained Maintain SOP/document control and training requirements Conduct and/or oversee internal audits and mock recalls Maintain FDA inspection readiness and support third-party/customer audits Oversee NSF certification implementation and ongoing compliance Verify correct raw ingredients are in use, correctly weighed and documented in LM and PB room Perform all duties of quality assurance staff, and other duties as assigned Reporting Relationship Reports to Plant Manager Qualifications 5+ years of quality control management experience in the dietary supplement or a related regulated industry Must possess a thorough working knowledge of 21 CFR Part 111 and understand its practical application to dietary supplement manufacturing and quality control Excellent verbal and written communication skills Excellent interpersonal and customer service skills Excellent organizational skills and attention to detail Excellent time management skills with a proven ability to meet deadlines Strong analytical and problem-solving skills Strong supervisory and leadership skills Proficient with Google Suite, Microsoft Office Suite, or related software Experience using Isolocity or other QMS software Abilities and competencies To perform the essential functions of the position, the incumbent regularly employs the following competencies, physical and/or sensory abilities and skills. Be able to reach, bend, stoop and frequently lift up to 50 pounds Be able to work in a standing position for long periods of time (up to 8 hours) Must understand and follow all safety and sanitation procedures Must be able to properly handle all equipment and report any equipment that is not functioning Work Schedule Full-time schedules. Work schedules may vary and could involve day and nighttime hours during the week and on weekends

Pay:

$90,000.00 - $110,000.00 per year

Benefits:

401(k) matching Paid time off Referral program

Work Location:

In person