Senior QA Document Control Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services in Bedford, NH, seeks a QA Specialist II - Document Control to manage cGMP documents and records. The role involves maintaining master documents, handling batch records, and supporting QA audits.

The position requires strong communication skills, extensive document control experience in biotech/pharma, and proficiency with eQMS and MS Office; on-site work in Bedford, NH is expected.

Qualifications

• High School Diploma and 10+ years industry experience, with at least 6 years in document control.
• Document Control and/or eQMS configuration and system management experience.
• Advanced knowledge of cGMPs, EU regulatory requirements, and FDA 21 CFR Parts 210,211, 820.
• Strong MS Office proficiency and experience with electronic Quality Management System tools.
• Ability to lead large or cross-functional projects and improvements.
• Excellent written and verbal communication across all organizational levels.

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 log books, room log books, and Quality System event documents.
• Maintain numbering logs for documents, materials, and batches.
• Write and develop QA SOPs with minimal oversight.
• Administer the filing system for records and documents.
• Proof and edit document changes including minor SOP updates.
• Participate in or lead audit preparation and reconciliation; support audit requests.
• Support metrics and report generation; cross-train for coverage.
• Lead continuous improvement projects across the department.
• Perform obsolete and administrative document workflow; lead investigations and CAPA items.
• Train others in doc control processes; develop new tools and processes.

Skills

Communication skills

Organizational skills

Attention to detail

Team oriented

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 documents and records. The role involves maintaining master documents, handling batch records, and supporting QA audits.

The position requires strong communication skills, extensive document control experience in biotech/pharma, and proficiency with eQMS and MS Office; on-site work in Bedford, NH is expected.