Senior Document Control Lead – GMP & Quality Compliance

NEPHRON SC, LLC; West Columbia (TX); On-site; USD 85,000 - 115,000; Full time

Job summary

NEPHRON SC, LLC is seeking a Document Control Manager to lead day-to-day document control operations, ensure accuracy and compliance of controlled documents, and oversee regulatory readiness across the organization in support of cGMP and FDA requirements.

You will manage batch records, development documents, and media fill documentation, mentor the Document Control team, partner with QA and manufacturing, and drive continuous improvement in records management and data integrity.

Qualifications

• Bachelor's degree in a related field preferred.
• Minimum 3–5 years of experience in document control or Quality Assurance in a regulated environment.
• Working knowledge of cGMP, FDA regulations, and data integrity principles.
• Experience with Document Management Systems (e.g., TrackWise, TrackWise Digital, Dot Compliance, Electronic Batch Records).

Responsibilities

• Oversee document control workflows, ensuring review, approval, issuance, revision, distribution, retrieval, archival, and disposition.
• Maintain version control, metadata, audit trails, access controls, and retention requirements for documents.
• Support regulatory inspections, audits, and quality-system activities related to document control.
• Lead and mentor the Document Control team; drive continuous improvement and data integrity.

Skills

cGMP knowledge

FDA regulations

Data integrity

Document control

Quality systems

Technical writing

Cross-functional collaboration

Mentoring/training

Microsoft Office

Adobe Acrobat

Education

Bachelor's degree in Business Administration, Life Sciences, or related field

Tools

TrackWise

TrackWise Digital

Dot Compliance

Electronic Batch Records

SharePoint

Microsoft Office Suite

Adobe Acrobat

Job description

NEPHRON SC, LLC is seeking a Document Control Manager to lead day-to-day document control operations, ensure accuracy and compliance of controlled documents, and oversee regulatory readiness across the organization in support of cGMP and FDA requirements.

You will manage batch records, development documents, and media fill documentation, mentor the Document Control team, partner with QA and manufacturing, and drive continuous improvement in records management and data integrity.