Quality Assurance Document Control Specialist

Thorne • Summerville, SC

2d

About The Position

The Quality Assurance Document Control Specialist maintains accurate, compliant, and organized controlled documents and quality records supporting Thorne’s Quality Management System (QMS) and manufacturing operations. The role manages document control for SOPs, work instructions, forms, specifications, formulas, master manufacturing records, and other controlled documents, supporting their creation, review, approval, distribution, maintenance, and archival in accordance with current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

The specialist also supports batch record preparation and review, quality transactions, product release activities, change management, and quality record maintenance. Working with Quality Assurance, Quality Control, Manufacturing, and cross-functional subject matter experts, the position helps ensure documentation is complete, approved, traceable, and available for compliant manufacturing and product disposition. The role requires strong organization, attention to detail, documentation skills, sound judgment, and the ability to manage priorities and resolve issues in a regulated manufacturing environment.

The scheduled shift is Tuesday through Saturday, 3:00 p.m. to 11:30 p.m. The position may require an assigned 8-hour or 10-hour shift and overtime as business needs require.

Requirements

• High school diploma or GED required.
• Demonstrated ability to manage detailed documentation accurately and consistently.
• Working knowledge of document control principles, controlled documentation, quality records, and record retention practices.
• Understanding of cGMP and GDP requirements as they apply to quality documentation and manufacturing records.
• Familiarity with SOPs, work instructions, specifications, forms, master manufacturing records, and related controlled documents.
• Ability to create, format, review, route, and maintain documentation within an electronic QMS.
• Understanding of document revision, change management, review, approval, and archival processes.
• Knowledge of batch record preparation, review, and documentation requirements.
• Ability to review manufacturing and quality records for completeness, accuracy, and compliance with established procedures.
• Ability to perform or learn quality-related transactions within an ERP system and learn Thorne’s ERP, document management, and change management systems.
• Proficiency with Microsoft Word and Excel.
• Ability to perform basic mathematical calculations involving whole numbers and decimals.
• Ability to interpret written procedures, technical documentation, and quality requirements and apply them accurately.
• Understanding of product disposition, release documentation, and batch certification processes as applicable to assigned responsibilities.
• Ability to perform assigned responsibilities through an appropriate combination of education, training, and relevant experience.
• Ability to work in an environment where ingredients and products may be derived from potentially allergenic sources, including nuts, soy, dairy, fish, and shellfish.
• Ability to remain stationary for extended periods, move throughout manufacturing, warehouse, quality, and administrative environments as required, and safely operate assigned equipment and office machinery.
• Ability to communicate effectively, read and review detailed documentation and small print, and work in moderate noise levels.
• Ability to occasionally lift or move items weighing up to 25 pounds between floor and table height.
• Ability to work an assigned 8-hour or 10-hour shift and overtime as business needs require.

Nice To Haves

• Relevant experience in Quality Assurance, document control, quality records management, manufacturing documentation, or a related discipline.
• Experience working within a cGMP-regulated manufacturing environment.
• Familiarity with controlled documents, quality records, batch documentation, and document review processes.
• Experience with electronic Quality Management Systems, document management systems, or change management workflows.
• Experience working with ERP systems or performing quality-related system transactions.

Responsibilities

• Create, format, edit, route, finalize, file, and maintain controlled documents in the QMS.
• Maintain controlled SOPs, work instructions, forms, specifications, formulas, master manufacturing records, policies, and other quality-related documents.
• Coordinate with subject matter experts and cross-functional stakeholders to ensure documents are accurate, complete, and appropriately reviewed and approved.
• Coordinate periodic document reviews and track completion within established timeframes.
• Maintain document records, revision histories, and supporting documentation in the QMS.
• Ensure required training documentation is completed for affected employees before revised documents are released.
• Guide internal stakeholders on document control processes and QMS requirements; identify documentation discrepancies and coordinate resolution.
• Support continuous improvement of document control processes, documentation accuracy, and QMS effectiveness.
• Create, review, and maintain manufacturing batch packets and ensure approved packets are available to Production within required timelines.
• Review completed batch order files for required, accurate, and complete documentation, including critical batch information such as expiration dates, work order numbers, lot numbers, and allergen identification.
• Review batch records and receiving reports to support product disposition decisions and ensure GDP and cGMP compliance.
• Perform applicable quality transactions in the ERP system, including product release transactions for materials or products that meet established requirements.
• Perform authorized batch certification responsibilities and support final batch certification in coordination with the Marketing Authorization holder.
• Maintain batch order records, release documentation, and quality logs; identify and escalate discrepancies or potential compliance concerns before product release.
• Receive, route, track, and maintain Change Requests in the QMS; coordinate review, approval, implementation, and documentation of approved changes.
• Maintain change management records, update applicable product checklists, route required actions, and monitor outstanding activities for timely completion.
• Partner with stakeholders to implement document changes consistently, troubleshoot revision and change management issues, and ensure approved changes are finalized and recorded.
• Scan, organize, file, archive, and maintain quality records according to retention requirements; maintain active Quality Assurance logs and provide information to stakeholders.
• Respond to Customer Service requests for Certificates of Analysis (COAs), coordinating with the Quality Control Laboratory when necessary.
• Maintain accurate, complete, legible, traceable, confidential quality records and regulated documentation.
• Perform assigned activities in compliance with cGMP, GDP, Quality Assurance SOPs, company procedures, and applicable regulatory requirements.
• Support inspection and audit readiness, identify documentation or compliance risks, and communicate concerns and recommended solutions.
• Collaborate with Quality Assurance, Quality Control, Manufacturing, and other departments; communicate requirements, approval status, outstanding actions, and potential delays.
• Independently manage assigned projects and responsibilities within established guidelines and timelines, provide clear records of completed work and findings, and participate in required technical and quality training.
• Identify opportunities to improve document accuracy, workflow efficiency, record management, and quality processes.
• Maintain attention to detail while managing multiple documentation, quality, and operational priorities.

Benefits

• Competitive compensation
• 100% company-paid medical, dental, and vision insurance coverage for employees
• Company-paid short- and long-term disability insurance
• Company-paid life insurance
• 401k plan with employer matching contributions up to 4%
• Gym membership reimbursement
• Monthly allowance of Thorne supplements
• Paid time off
• Volunteer time off
• Holiday leave
• Training, professional development, and career growth opportunities

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED