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Jobs

Zarbee's Naturals

Contact: Mark Andersen

Address: 11650 South State Street Address Suite 101, Draper, Utah 84020

Employment Opportunity: Senior Quality Manager

Duties and Responsibilities

Represent Zarbee’s QA by performing product assessments and reviews of external manufacturing. Represent QA
on project teams to ensure all regulatory and J & J requirements are meet. Provide compliance input on project
issues and perform Quality review of development, stability, technical transfer, regulatory filings and change
controls as needed.


Responsible for supporting the strategy and organization evolution to ensure sustained compliance and meet the
needs of the business (including 21 CFR 111 and Cosmetics) as required. Support the establishment of new/revised
Technical Quality System Policies and Procedures driven by changes in regulations, J&J Standards, product
portfolio or business strategies to assure that the products meet internal J&J and external regulatory requirements.

Essential

  • Ensure that external manufactures of Zarbee’s products meet necessary quality standards as outlined in 21 CFR 111 and 21 CFR 117.
  • Develop and implement product specifications and standard operating procedures (SOPs)
  • Provide ongoing support by helping to create new documents, reviewing and revising existing documents, and verifying that the documents are aligned with relevant regulations.
  • Review protocols (stability), summary reports (customer complaints), SOPs, and internal specifications to ensure that documentation is accurate and complete.
  • Provide final approval and sign-off on customer complaints, SOP’s, and internal specifications.
  • Create CCR’s as appropriate and support entry into the document management system.
  • Help to establish stability testing programs with R&D and participating manufacturers and ensure ongoing compliance
  • Provide document support to Document Control Specialist
  • Follow cGMP practices, policies and procedures.
  • Provide training as required.
  • Perform record reviews of batches supplied by co-manufactures.
  • Sign-off on product release as required by 21 CFR 111.
  • Approve documentation for ensuring dietary supplements meeting identity, strength, purity and composition.
  • Review documents assess risk and create GAP analysis based on current FDA regulations.
  • Help with the development of programs to eliminate or reduce risks as identified in GAP analysis.
  • Help to maintain electronic document management system and ensure documents are current.
  • Participate or lead internal quality reviews of documentation, training records, stability programs, CAPA’s
  • Investigate and resolve product and process problems related to quality issues.
  • Participate in investigations of customer complaints; working with manufactures and operations to
  • resolution.
  • Ensure CAPA’s are properly documented and corrective actions taken
  • Prepare and give technical presentations as required.
  • Maintain company quality assurance archives.
  • Travel to external manufacture locations to work audit and work with co-packers.

Additional

  • Review company labels and literature for technical accuracy and regulatory compliance.
  • Understand and adhere to GMP policies and Procedures.
  • Provide ongoing technical assistance and problem solving with existing manufacturers and suppliers, leveraging industry experiences and best practices.
  • Lead the process for gaining and maintaining compliance US regulatory agencies as necessary
  • Participate in communication with the FDA or other regulatory agencies as needed
  • Perform other duties as assigned or needed.


Qualifications/Knowledge, Skills, and Abilities Requirements

  • Must have a bachelor’s degree in biology, biochemistry, nutrition, food science, or related science field.
  • 10 years’ experience in a manufacturing environment (Pharmaceutical, Dietary Supplements or Food) with Good Manufacturing Practices.
  • Minimum of 3 years’ experience working in close support with R&D, Operations and Quality.
  • 3 years management experience.
  • Strong written and oral communication skills.
  • Ability to supervise and give directions.
  • Ability to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to others or self.
  • Must be able to travel

Machines Typically Operated

  • COMPUTER, OPERATING SYSTEMS, REPORTING PACKAGES, TELEPHONE, FAX, ETC.

Typical Physical Requirements

    • Frequently involves sedentary work exerting up to 10 pounds of force occasionally and/or negligible force frequently or constantly.
    • Involves a variety of physical activities including:
    • Walking
      • Talking
      • Hearing
      • Repetitive Motions
      • Visual acuity required is the minimum standard for use with those whose work deals largely with preparing and analyzing data and figures, accounting, transcription, computer terminals, extensive reading, visual inspection involving small defects, handling small parts, operation of simple machines, using measurement devices, assembling, or fabrication of parts at distances close to the eyes.

Typical Environmental Conditions

    • The worker is not substantially exposed to adverse environmental conditions. This is a typical office or administrative environment.

DOCUMENT CONTROL

Duties and Responsibilities

  • The QA Document Analyst will help review and revise specifications and SOP's.
  • Create change control records with in an electronic data base system. Create and develop SDS documents in The Wercs system.
  • Review and assist in investigations of customer complaints to ensure accuracy and compliance with FDA regulations (21 CFR 111).
  • Work with our co-manufactures to obtain production records or release documents.
  • Responsible for supporting the strategy and organization evolution to ensure sustained compliance and meet the needs of the business (including 21 CFR 111 and Cosmetics) as required.
  • Support the establishment of new/revised Technical Quality System Policies and Procedures driven by changes in regulations, J&J Standards, product portfolio or business strategies to assure that the products meet internal J&J and external regulatory requirements.

Essential

  • Provide ongoing support by helping to create new documents, reviewing and revising existing documents, and verifying that the documents are aligned with relevant regulations.
  • Assist in review of protocols, summary reports (customer complaints), SOPs, and internal specifications to ensure the document is accurate and complete.
  • Follows cGMP practices, policies and procedures.
  • Perform record reviews of batches supplied by co-manufactures.
  • Review documents assess risk and create GAP analysis based on current FDA regulations.
  • Help to maintain electronic document management system and ensure documents are current.

Additional

  • Provide tracking and trending documentation as needed in support of customer complaints.
  • Create SDS documents through for retailors through the WERCs system.
  • Review older SOPs and specifications and help in the revision or archiving as needed.
  • Perform other duties as assigned or needed.

Qualifications/Knowledge, Skills, & Abilities Requirements

  • Must have a high school degree or equivalent
  • 1 – 3 years’ experience in food, dietary supplements or pharmaceuticals, a plus.
  • QA/QC or manufacturing experience helpful
  • Knowledge of GMP, FDA trends and guidelines helpful
  • Strong computer skills, knowledge of excel and word.
  • HACCP, SOF, HARPC helpful
  • Strong written and oral communication skills.
  • Ability to efficiently and effectively perform all essential position duties and responsibilities with or without reasonable accommodation without posing a direct safety threat to others or self.

Machines Typically Operated

  • Computer, operating systems, reporting packages, telephone, fax, etc.

Typical Physical Requirements

  • • Frequently involves sedentary work exerting up to 10 pounds of force occasionally and/or negligible force frequently or constantly.
  • • Involves a variety of physical activities including: Walking Talking Hearing Repetitive Motions
  • • Visual acuity required is the minimum standard for use with those whose work deals largely with preparing and analyzing data and figures, accounting, transcription, computer terminals, extensive reading, visual inspection involving small defects, handling small parts, operation of simple machines, using measurement devices, assembling, or fabrication of parts at distances close to the eyes.

Typical Environmental Conditions

  • The worker is not substantially exposed to adverse environmental conditions. This is a typical office or administrative environment.