Specialist, Document Control and Records Management

Job Summary

A top-tier global pharma leader is seeking a Document Control Specialist to manage critical paper and electronic document workflows in a fast-paced, cutting-edge production environment.

Responsibilities

• Administer paper-based and electronic document workflows (eDMS), including document requests, approvals, and precise chain-of-custody tracking.
• Issue and reconcile critical GMP manufacturing records, logbooks, and validation protocols.
• Manage the complete lifecycle and secure archival of on-site and off-site GMP documentation.
• Revise standard operating procedures (SOPs) and work instructions to optimize records management.
• Provide frontline document control support during internal and external regulatory inspections.

Qualifications

• Education: BS or MS degree, preferably in Sciences or Engineering.
• Experience: 3-5 years of Quality Assurance experience in the pharmaceutical industry with a BS, OR 2+ years with an MS.
• Compliance: Strong, demonstrated understanding of GxP regulations, Good Documentation Practices (GDP), and regulatory data integrity requirements.

Skills

• SOP
• Quality Assurance
• GMP (Good Manufacturing Practice)

Benefits

Includes medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).