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Director of Quality and Compliance

Biovation Labs West Valley City ,UT
  • Posted: 22 days ago
  • Full-Time
  • Benefits: dental, medical, vision, 401k
Job Description

 

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.

Job Requirements:

  • 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.
Company Description
Biovation 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.

Biovation Labs

Biovation 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.

Address

2323 S 3600 W
West Valley City, UT
USA

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