QMS Investigator I

PCI Pharma Services seeks a QMS Investigator I to support investigations and documentation of manufacturing deviations, complaints, and quality issues in a cGMP environment. Under direct supervision, the role involves authoring technical documents, coordinating cross-functional reviews, and tracking resolution of operational concerns.

Responsibilities

• Initiate and support timely completion of manufacturing investigations and issue resolution
• Author and revise deviations, complaints, and technical documentation
• Manage specific components of large-scale deviations and track relevant data
• Provide support for internal, client, and regulatory audits as needed
• Follow up on open documents to ensure timely close-out of batch records and investigations

Requirements

• High school diploma or equivalent required
• 1–3 years relevant experience in cGMP manufacturing environment
• Strong written and verbal English communication skills
• Detail-oriented with proficiency in Microsoft Office applications
• Familiarity with technical documentation (deviations, CAPAs, SOPs) preferred
• Ability to work independently and as part of cross-functional teams

Compensation: $21.69–$24.41 per hour plus annual performance bonus eligibility