Job Description

PCI Pharma Services seeks a QMS Investigator II to conduct moderately complex investigations into out-of-specification events and deviations in a cGMP environment. The role involves writing technical documentation, coordinating cross-functional teams, and supporting compliance activities across manufacturing operations and quality functions.

Responsibilities

• Initiate and support moderately complex investigations and resolution of QMS and operations issues
• Coordinate interdisciplinary teams and develop recommendations for investigations and change controls
• Author and revise change controls and technical documentation
• Manage components of moderate-scale deviations and track data trends
• Support internal, client, and regulatory audits as needed

Requirements

• High school diploma or equivalent; bachelor's degree in life sciences preferred
• 3-5 years relevant experience in cGMP environment, manufacturing preferred
• Understanding of equipment, systems, and technologies for issue documentation
• Previous experience conducting investigations preferred
• Experience writing technical documentation (deviations, CAPAs, SOPs) preferred
• Knowledge of aseptic processing and compliance experience preferred

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