QA Document Control Specialist II - Compliance & Audits

PCI Pharma Services; Bedford (NH); On-site; USD 70,000 - 90,000; Full time

Job summary

PCI Pharma Services in Bedford, New Hampshire is seeking a QA Specialist II - Document Control responsible for managing documents, ensuring compliance with cGMP standards, and maintaining quality management systems. The ideal candidate should have extensive experience in document control specifically in the Biotech or Pharmaceutical industries and demonstrate advanced knowledge of FDA regulations.

The role requires excellent organizational skills and the ability to lead improvement initiatives across multiple departments. Join us in delivering life-changing therapies.

Qualifications

• At least 10 years of industry experience with a minimum of 6 years document control experience in Biotech/Pharmaceutical industries.
• Advanced knowledge of cGMPs and FDA regulations is required.
• Strong communication skills across all levels of the organization.

Responsibilities

• Manage, coordinate, and maintain cGMP documentation and records.
• Facilitates workflows in electronic document management systems.
• Lead quality system investigations and CAPA action items.

Skills

Document Control

cGMP knowledge

MS Office

Project management

Customer service

Education

High School Diploma

Tools

Electronic Quality Management System

Document Management Software

Job description

PCI Pharma Services in Bedford, New Hampshire is seeking a QA Specialist II - Document Control responsible for managing documents, ensuring compliance with cGMP standards, and maintaining quality management systems. The ideal candidate should have extensive experience in document control specifically in the Biotech or Pharmaceutical industries and demonstrate advanced knowledge of FDA regulations.

The role requires excellent organizational skills and the ability to lead improvement initiatives across multiple departments. Join us in delivering life-changing therapies.