QA Specialist II – Document Control Expert

pciservices; Bedford (NH); On-site; USD 70,000 - 100,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a QA Specialist II - Document Control to manage cGMP documentation and records, ensuring controlled copies are reviewed, approved, issued, distributed, and archived. You will maintain databases and QMS tools, support personnel across the QA environment, and contribute to program improvements.

The role focuses on maintaining Master Documents, enabling efficient document workflows, and supporting audits and CAPA actions with minimal supervision.

Qualifications

• High School Diploma required with at least 10 years of industry experience; minimum 6 years in document control within biotech, pharma, or medical devices.

Responsibilities

• Maintain Quality System Master Documents and Master Document List.
• Facilitate workflows in the electronic document management system and legacy paper processes.
• Create, modify, and approve Client Batch Records.
• Issue and reconcile batch records, testing data capture sheets, lab books, equipment logs, and Quality System event documents.
• Maintain document, material and batch numbering logs.
• Write and develop QA SOPs with minimal oversight.
• Administer the maintenance of the Record/Document filing system at designated sites.
• Lead audit preparation and reconciliation; support audit requests; perform internal audit tasks.
• Support metrics/report generation.
• Cross-train and provide coverage across multiple production facilities as needed.
• Lead continuous improvement efforts in document control and related tools.
• Train others in doc control processes.
• Develop and implement new tools for Document Control with minimal oversight.

Skills

Attention to detail

Documentation

Communication skills

Organizational skills

Decision making

Education

High School Diploma

Tools

MS Office

eQMS

Job description

PCI Pharma Services in Bedford, NH seeks a QA Specialist II - Document Control to manage cGMP documentation and records, ensuring controlled copies are reviewed, approved, issued, distributed, and archived. You will maintain databases and QMS tools, support personnel across the QA environment, and contribute to program improvements.

The role focuses on maintaining Master Documents, enabling efficient document workflows, and supporting audits and CAPA actions with minimal supervision.