Validation & QMS Associate

Tailstorm Health IncChandler, AZ
Onsite

About The Position

The Validation & QMS Associate supports validation documentation, data collection, and quality system activities in Medivant’s sterile injectable facility. This entry-level role is ideal for recent graduates seeking hands-on cGMP and aseptic processing experience.

Requirements

  • Bachelor’s degree in Pharmacy, Biotechnology, Microbiology, Life Sciences, or related field.
  • 2-3 years of relevant experience is required
  • Understanding of aseptic and sterile processing.
  • Strong documentation and communication skills.

Nice To Haves

  • Experience in sterile manufacturing or validation support.
  • Knowledge of QMS processes and cGMP environments.

Responsibilities

  • Assist in execution of media fill studies and documentation.
  • Support area qualification and environmental monitoring tasks.
  • Help draft IQ/OQ/PQ protocols and assist execution.
  • Collect data for HVAC, WFI, and compressed air validation.
  • Assist in cleaning validation logs and sample documentation.
  • Participate in process validation protocol preparation.
  • Support change control documentation.
  • Assist in deviation data collection and preliminary reports.
  • Track CAPA activities and closure evidence.
  • Ensure cGMP compliance in all assigned tasks.
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