Operations – QA Manager

The successful candidate will assist with the creation of a strong food safety culture and provide Quality Assurance oversight for current Good Manufacturing Practice (GMP) manufacturing operations to assure compliance with regulatory requirements, including development, implementation, maintenance, and performance of quality assurance systems and programs in accordance with CFR Title 21 Part 111 for dietary supplements and National Animal Supplement Council’s Quality System requirements for all products intended for animal consumption. The Nitty Gritty:

  • Refine, maintain and continually improve comprehensive quality management system, including compliance with quality manual and policies
  • Supervises, trains, and develops staff in accordance with current (c)GMPs and other regulatory areas as needed
  • Ensure products are being manufactured according to GMP/QC specifications and according to label claims.
  • Oversee inspection, acceptance, and disposition of product and product shipments (incoming & outgoing).
  • Generates and maintains SOP’s for the quality department and ensures written procedures regarding Manufacturing batch records, Validation, Quality, and Laboratory practices and standards are met under cGMP’s.
  • Leads investigations in nonconformance events, facilitates CAPA and root cause analysis.
  • Performs in house and critical supplier audits as needed.
  • Perform training on cGMP manufacturing practices, monitors and ensures compliance via QA oversight of production and warehouse floor activities.
  • Continually evaluates quality systems supporting GMP manufacturing operations for potential improvements.
  • Generates and evaluates monthly or quarterly reports and metrics to measure quality attributes in manufacturing operations.
  • Implements corrective and preventive actions to address adverse trends and quality systems gaps.
  • Report all Adverse Events and Recalls to the appropriate authorities
  • Represents QA in various cross functional process improvements teams including new product initiation projects.
  • Oversee micro-testing lab requirements.
  • Represents and supports the quality assurance department in frequent client, regulatory and supplier audits.
  • Monitors changes to state and federal regulations pertaining to dietary supplements, pharmacy operations, and environmental compliance.
  • Serve as audit host with other senior management team for any governmental or outside audits/inspections.
  • Serves as Document Control Manager.
  • Develop and manage a team of quality control technicians.
  • Assists in the technical development, review and approval of GMPs and Pharmacy regulations..
  • Other duties as assigned.

Position Must Have’s:

  • Completed Bachelor’s degree in a Life Sciences discipline or equivalent
  • Six to Eight (6-8) years of relevant experience in a drug, dietary supplement or food industry
  • Three (3) years in a quality managerial position performing Quality Assurance function
  • Working knowledge of cGMPs, FDA regulations, and Pharmacy regulations
  • Detail oriented and strong written and verbal communication skills
  • Ability to work independently, within prescribed guidelines, or as a team member
  • Demonstrated ability to follow detailed directions in a laboratory environment
  • Solid knowledge of Microsoft Office
  • Excellent communication and interpersonal skills
  • Sense of humor

Interested? Apply now!

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One comment on “Operations – QA Manager
  1. Jennifer Clements says:

    Good Morning! Has the position of QA Manager been filled? If not, is there a closing date? Thanks so much!

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