The Quality and Compliance Manager is responsible for the management of all aspects of Quality Control & Assurance, including quality systems, improvement of quality systems and compliance, FDA audits, NSF audits and vendor/customer audits.
- Ultimate responsibility for all cGMP compliance and FDA regulations.
- Ensure cGMPs & SOPs are up to date and being adhered to by all employees of Biovation Labs.
- Oversee and approve all new SOPs, when necessary, update SOPs in a timely manner to ensure they are current and valid.
- Lead facility audits and follow up with any necessary responses or documents.
- Represent the Quality Department at leadership meetings.
- Oversee re-qualification of expired raw materials according to GMPs.
- Review and approve specifications, master manufacturing record, batch records and other quality documents (Deviations, Rework, CAPA).
- Conduct customer complaint investigations.
- Responsible for filing of CAPA reports and investigations.
- Conduct out of specification/deviation investigations when required.
- Responsible for overseeing and managing the skip lot testing program.
- In charge or approving and validating all artwork to be used within manufacturing.
- Qualify third party vendors in conjunction with supply chain management.
- Responsible for obtaining data on KPI’s to provide to the leadership team.
- Assist in Recall procedures and responsible for initiating yearly mock recalls.
- Serve on the Material Review Board for the removal and destruction of raw materials and components from inventory.
- Participate in the development of continuous improvement plans, including processes and guidelines to assist in streamlining regulatory systems and operations.
- Bachelor’s Degree in a related field with five years of experience or nine years of Quality and Compliance experience
- Excellent analytical and problem solving tools
- Effective communication skills both verbally and in writing
- Understand and abide by 21 CFR Part 111, FSMA, and 21 CFR Part 117.
We are certified by NSF International as a Good Manufacturing Practices manufacturer, and operate a number of facilities inspected and audited by the FDA on a regular basis. Our team's collective experience in this industry is unparalleled, and we have an unwavering commitment to quality in all things--including the people we hire and work with.
Biovation LabsBiovation Labs is a dynamic company that does private label and contract manufacturing of nutraceutical products that can be found online and in major health and nutrition stores. We're a company that partners with our employees and clients to develop industry-leading products that are introduced through channels both new and traditional. We are certified by NSF International as a Good Manufacturing Practices manufacturer, and operate a number of facilities inspected and audited by the FDA on a regular basis. Our team's collective experience in this industry is unparalleled, and we have an unwavering commitment to quality in all things--including the people we hire and work with.
West Valley City, UT