QA Specialist II - Doc Control

PCI Pharma Services seeks a QA Specialist II for Document Control in Bedford, New Hampshire to manage cGMP documentation, procedures, and records while maintaining compliance with regulatory standards. The role involves coordinating document workflows, maintaining quality management systems, and leading continuous improvement initiatives across the organization.

Responsibilities

• Manage quality system master documents, master document lists, and maintain document numbering logs
• Facilitate workflows in electronic document management systems and legacy paper processes
• Create, modify, and approve client batch records, testing data sheets, and quality system event documents independently
• Lead quality system investigations, CAPA action items, and audit preparation activities
• Develop and implement QA procedures and new document control tools with minimal oversight; train personnel on processes

Requirements

• High school diploma with minimum 10 years pharmaceutical, biotech, or medical device industry experience
• Minimum 6 years document control experience in regulated life sciences environments
• Advanced knowledge of cGMP, FDA 21 CFR Parts 210, 211, and 820, and EU regulatory requirements
• Document control and eQMS configuration and system management experience
• Working knowledge of computer system validation and change control requirements
• Proficiency in MS Office and electronic quality management systems