COORDINATOR QUALITY

VIVOS HOLDINGSSmyrna, TN
Onsite

About The Position

The Quality Coordinator is responsible for processing all Standard Operating Procedures (SOPs), including updating the intranet site and maintaining the SOP training database. This role also involves compiling and processing Annual Product Reviews for drug products and required cosmetics, and maintaining Quality Management tasks within the SAP workflow system. Accuracy is paramount due to the sensitive nature of testing and regulatory information.

Requirements

  • Must demonstrate a working knowledge of chemical analysis and laboratory bench work.
  • Must have a working knowledge of computer usage including experience and ability to troubleshoot in SAP, spreadsheets, word processing, and database packages.
  • Must understand FDA regulations that are relative to product testing.
  • Requires excellent oral and written communication skills.
  • Excellent organization skills.
  • Ability to analyze data.
  • Ability to handle stress and work with multiple priorities independently.
  • Ability to interface effectively with other departments.
  • Demonstrates excellent analytical and decision-making ability.
  • Must be able to work on multiple projects in a fast-paced environment and critically review analytical and related data to prepare technical reports in accordance with all cGMPs.
  • Must be able to coordinate workload and work under pressure.
  • Has a professional, helpful attitude accepts constructive criticism well, and is a team player.
  • Proficient in Microsoft Office products including a minimum of 2 years computer software experience in a work environment.
  • Proficient in Excel; basic understanding of Word.
  • Basic laboratory skills required including pipetting and analytical dilutions.

Nice To Haves

  • A Bachelor’s degree in a related field is preferred.
  • QA, QC or working in a GMP environment is preferred.

Responsibilities

  • Maintain QM tasks in SAP workflow, ensuring accuracy for sensitive testing and regulatory information.
  • Ensure all SOPs are processed in compliance with GMPs, including maintaining change control records, issuing review records, and acquiring QA and department approval before activating SOPs on the intranet.
  • Maintain a SOP training database for the Tennessee site.
  • Maintain Annual Product Review data for the site, compiling information from QC, PD, batch records, etc., for all drug products and cosmetic products for key customers.
  • Conduct the quality training portion of New Employee Orientation.
  • Assist with customer specification requests.
  • Assist QA Management with special projects as requested.
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