QA Document Control Specialist II - cGMP Expert

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 70,000 - 95,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a QA Specialist II – Document Control to manage cGMP documentation, master documents, and records. You will coordinate document workflows, prepare batch records, and support audits to ensure compliant release of controlled documents.

The role requires a high school diploma with extensive document control experience in biotech/pharma and strong communication, organizational, and problem-solving skills.

Qualifications

• High School Diploma and 10+ years in industry with 6+ years in document control in biotech/pharma/medical device.
• Strong written and verbal communication across levels.
• Experience with cGMPs, FDA/EU requirements is preferred.

Responsibilities

• Maintain Quality System Master Documents and Master Document List.
• Facilitate workflows in electronic document management systems.
• Create, modify and approve client batch records.
• Issue and reconcile batch records, lab books, and quality system documents.
• Lead audit preparation and support audit requests.
• Train others in document control processes and develop new tools.

Skills

Communication skills

Attention to detail

Organizational skills

Decision making

Project leadership

Education

High School Diploma

Tools

MS Office

eQMS systems

Job description

PCI Pharma Services in Bedford, NH seeks a QA Specialist II – Document Control to manage cGMP documentation, master documents, and records. You will coordinate document workflows, prepare batch records, and support audits to ensure compliant release of controlled documents.

The role requires a high school diploma with extensive document control experience in biotech/pharma and strong communication, organizational, and problem-solving skills.