QA Document Control Manager – GMP Leader

PCI TRGR Penn Pharmaceutical Services Ltd; Bedford (NH); On-site; USD 90,000 - 110,000; Full time

Job summary

PCI Pharma Services in Bedford, NH seeks a Manager of QA Document Control to lead and optimize the QA Document Control function across multiple production facilities in a GMP setting. You will guide the lifecycle management of controlled documents, SOPs, and records, ensuring regulatory alignment and efficient processes.

The role requires mentoring staff, improving document systems, and supporting audits and client interactions, with travel and lifting as described in the job posting.

Qualifications

• Bachelor's degree in a related field with 5-8 years of FDA-regulated experience.
• 5+ years Document Control experience in GMP environments.
• Experience with electronic Quality Management Systems (MasterControl preferred).

Responsibilities

• Lead QA Document Control across multiple facilities in a GMP environment.
• Oversee issuance, revision, archiving of GMP-controlled documents and batch records.
• Manage eQMS document module and drive system improvements.
• Collaborate with cross-functional teams and support client audits and regulatory inspections.

Skills

QA Documentation

Document Control

Leadership

Cross-functional Collaboration

SOP Writing

Education

Bachelor's degree in related field

Tools

MasterControl

Job description

PCI Pharma Services in Bedford, NH seeks a Manager of QA Document Control to lead and optimize the QA Document Control function across multiple production facilities in a GMP setting. You will guide the lifecycle management of controlled documents, SOPs, and records, ensuring regulatory alignment and efficient processes.

The role requires mentoring staff, improving document systems, and supporting audits and client interactions, with travel and lifting as described in the job posting.