Quality Assurance Coordinator I

PharmaviteSanta Clarita, CA
$40,000 - $74,000Onsite

About The Position

This role is responsible for tracking, reviewing, and evaluating all processing documents accompanying the manufacture and packaging of products. The Quality Assurance Coordinator I prepares final documents for product disposition and assists QA Leaders in monitoring support on the packaging floor. The role reports to the shift Quality Leader and is crucial for ensuring on-time batch record releases with 100% accuracy. The position is not eligible for immigration sponsorship.

Requirements

  • HS Diploma or GED equivalent with mathematics as a required course.
  • One to three years’ experience in a manufacturing environment.
  • Ability to speak, read, and write English.
  • Good communication and interpersonal skills.
  • Computer skills in data entry and processing.
  • Ability to conduct mathematical calculations.
  • Attention to detail.

Nice To Haves

  • Exposure to chemistry and college mathematics would be a plus.
  • Experience in Quality is preferred.
  • Working knowledge of equipment, safety, quality, and computer systems.

Responsibilities

  • Independently reviews and approves batch record documentation.
  • Assembles and reviews all manufacturing or packaging documents, processing steps, and laboratory test records.
  • Samples, inspects, and reviews documentation of components, labels, and finished goods for proper disposition.
  • Calculates product yields and reconciles deviations.
  • Reviews non-conformance reports (NCRs) and change controls for completion and accuracy.
  • Releases product if all required documents are complete, accurate, and results are within established specifications.
  • Approves batch record minor NCRs.
  • Approves batch production change control NCRs, as needed.
  • Communicates problems to production supervisors and/or managers.
  • Resubmits documentation for corrective action, where required.
  • Enters processing document information into the computer system database.
  • Reports findings to QA/QC supervisor and/or managers, where required.
  • Makes recommendations for corrective actions.
  • Enters disposition into the computer system.
  • Prepares reject notices for non-conforming product, components, or labels.
  • Attends meetings and communicates daily quality performance.
  • Conducts in-process audits and testing as assigned in order to support company programs and established procedures.
  • Supports department, site, and company KPIs, pQRFT, and dQRFT metrics.
  • Problem-solves and troubleshoots production issues related to quality and/or operational issues while meeting deadlines.
  • Communicates effectively, verbally and in writing, with multiple levels of employees and across multiple functions.
  • Acts as a subject matter expert in their work area to aid in the identification of sustainable solutions to address systemic issues.

Benefits

  • Medical, dental, and vision benefits
  • 401K match
  • Other wellness benefits
  • Compensation for all overtime hours worked by non-exempt (hourly) employees in accordance with state and federal law.
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