Quality Coordinator

Responsibilities

• Prepare and distribute required documentation for production work orders
• Perform documentation reviews of completed and in-process orders to ensure compliance with cGMP and customer requirements
• Review and interpret customer standards, procedures, and specifications for batch records and material specifications
• Prepare customer-required samples for shipment according to approved instructions
• Prepare and submit batch records, accountability reports, and necessary documentation to facilitate product release
• Organize internal and customer approvals for batch records and specifications
• Identify, communicate, track, and resolve document-related issues with other departments and customers
• Act as a customer point of contact for questions pertaining to batch records
• Initiate supplier non-conformance reports and prepare planned deviation requests when needed
• Adhere to all PCI and cGMP policies, procedures, rules, and regulations

Requirements

• High school education and experience working in a cGMP environment
• Proficiency with personal computers and MS Office
• Proficiency with technical software, specifically Master Control
• Strong organizational, time management, and multi-tasking skills
• Ability to solve practical problems and interpret instructions in various formats (written, oral, diagram, or schedule)

Preferred Qualifications

• College degree with a concentration in a scientific discipline
• Lean Six Sigma or process improvement training

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.