Senior Document Control & Compliance Manager

RXinsider LTD.; West Columbia (SC); On-site; USD 85,000 - 115,000; Full time

Job summary

RXinsider LTD. is seeking a Document Control Manager to lead day-to-day document control operations, ensuring accuracy, currentness, and accessibility of controlled documents for quality, regulatory, and production teams.

You will oversee batch records, electronic records, and QA interactions, ensuring compliance with cGMP and FDA requirements. The role includes coaching the Document Control staff, enforcing version control, and driving continuous improvement in records management across the

Qualifications

• Bachelor’s degree in Business Admin, Life Sciences, or related field.
• 3–5 years in document control/QA in regulated environment.
• Experience with cGMP, FDA regs, and data integrity.
• Hands-on with DMS (TrackWise, TrackWise Digital, Dot Compliance, EBRs).
• Experience with batch record lifecycle management.
• Supervisory or team lead experience preferred.
• Audits/regulatory inspections experience preferred.

Responsibilities

• Oversee document control workflows and compliance.
• Manage batch records and media fill documentation.
• Maintain master documents and PD numbers.
• Lead document control team and provide guidance.
• Support regulatory inspections and CAPA.
• Collaborate with QA, PD, Manufacturing.
• Maintain QA documentation and training records.
• Ensure ALCOA+ data integrity across docs.

Skills

cGMP

FDA regulations

Data integrity

Document control

Records retention

Batch records

PD documents

Document review

Writing

Analytical

Organizational

Cross-functional

Leadership

MS Office

Adobe Acrobat

Education

Bachelor's degree in related field

Tools

TrackWise

TrackWise Digital

Dot Compliance

Electronic Batch Records

Job description

RXinsider LTD. is seeking a Document Control Manager to lead day-to-day document control operations, ensuring accuracy, currentness, and accessibility of controlled documents for quality, regulatory, and production teams.

You will oversee batch records, electronic records, and QA interactions, ensuring compliance with cGMP and FDA requirements. The role includes coaching the Document Control staff, enforcing version control, and driving continuous improvement in records management across the