Senior Associate, Documentation

TITLE: Senior Associate, Documentation
TYPE: Direct Hire
LOCATION: Apex, NC
ONSITE/REMOTE/HYBRID: Onsite
START DATE: February/March 2026

The Senior Associate for Documentation plays a key and central role in building and maintaining the documentation backbone of a growing 503B sterile manufacturing site. This position manages document control activities within Master Control, supports SOP/documentation deployment, and ensures that records across the operation remain organized, compliant, and audit-ready.

This is a hands-on role in a lean environment. It requires someone who brings structure, accuracy, and a calm, methodical approach to managing high volumes of documentation. Someone who understands that clean records are the foundation of a compliant and efficient operation.

KEY RESPONSIBILITIES

• Manage the full document lifecycle within Master Control, including creation, routing, approval, issuance, and archival.
• Coordinate closely with QA and external vendors to load new SOPs, templates, and controlled documents.
• Ensure revisions are issued correctly, and employees receive accurate, current versions in training assignments.
• Maintain strict version control and ensure documents follow site formatting, numbering, and structural standards.
• Support change control documentation, ensuring updates are reflected across impacted procedures and records.
• Review documents for clarity, completeness, compliance, and alignment with cGMP and 503B expectations.
• Prepare and organize documentation packets for audits and inspections.
• Track training assignments related to new or revised documents and support sitewide training compliance.
• Provide hands-on support across QA activities when documentation or data organization is required.
• Bring a structured, get-things-done mindset to keep documentation flowing in a fast-moving operation.

• Bachelor's degree preferred (Life Sciences, Quality, or related discipline).
• Three to five years of experience in document control within pharmaceutical, biotech, medical device, or similarly regulated industry.
• Strong familiarity with cGMP and document control expectations for regulated environments.
• Experience working with electronic quality systems, ideally Master Control.
• Exceptional organization and attention to detail; able to manage complex document workflows with accuracy.
• Comfortable working hands-on and supporting a lean QA organization where ownership and follow-through matter.