QMS Investigator III Job at PCI Pharma Services, San Diego, CA

  • PCI Pharma Services
  • San Diego, CA

Job Description

PCI Pharma Services seeks a QMS Investigator III to conduct investigations and author quality documentation for pharmaceutical manufacturing operations in San Diego. The role handles semi-complex deviations, change controls, and cGMP documents with cross-functional coordination across multiple departments.

Responsibilities

  • Initiate and support semi-complex investigations and resolution of operational issues
  • Author and revise change controls, deviations, and technical cGMP documentation
  • Coordinate interdisciplinary teams and provide recommendations for investigations and risk assessments
  • Track, trend, and manage closure of quality documents to enable timely product release
  • Support internal, client, and regulatory audits as needed

Requirements

  • High school diploma or equivalent; bachelor's degree in life sciences preferred
  • 5-7+ years experience in cGMP manufacturing environment
  • Proven experience initiating and supporting investigations
  • Experience writing technical documentation including deviations and SOPs
  • Knowledge of aseptic processing and regulatory compliance
  • Strong understanding of equipment, systems, and documentation practices

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