Quality Assurance Document Control Specialist (Weekend Shift)

Thorne • Summerville, SC

9h

About The Position

The Quality Assurance Document Control Specialist maintains accurate, compliant, and organized controlled documents and quality records that support Thorne’s Quality Management System (QMS) and manufacturing operations. The role manages document control activities 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 role helps ensure documentation is complete, approved, traceable, and available for compliant manufacturing and product disposition. The position requires strong organization, attention to detail, documentation skills, and the ability to manage priorities and resolve issues in a regulated manufacturing environment.

The shift is Friday through Monday, 1:00 p.m. to 11:30 p.m. The role may require an assigned 8-hour or 10-hour shift and overtime as business needs require.

Requirements

• High school diploma or GED.
• 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 ERP transactions and effectively 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.
• Strong attention to detail, organization, prioritization, communication, problem-solving, accountability, and cross-functional collaboration.
• Ability to recognize documentation, quality, or compliance concerns and promptly escalate issues requiring additional review.
• Ability to manage multiple priorities and work independently within established procedures and guidelines.
• Ability to safely work around ingredients and products that may be derived from allergenic sources, including nuts, soy, dairy, fish, and shellfish.
• Ability to remain stationary for extended periods, move through manufacturing, warehouse, quality, and administrative environments, and safely operate assigned equipment and office machinery.
• Ability to communicate effectively and read and review detailed documentation and small print in printed and electronic formats.
• Ability to work in moderate noise levels and 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 within the QMS.
• Maintain SOPs, work instructions, forms, specifications, formulas, master manufacturing records, policies, and other quality-related documents.
• Coordinate with subject matter experts and stakeholders to ensure documents are accurate, complete, and reviewed appropriately.
• Coordinate document review and approval processes, periodic reviews, revision histories, and training documentation for affected employees.
• Provide guidance on document control processes and QMS requirements, identify documentation discrepancies, and support resolution and continuous improvement.
• Create, review, and maintain manufacturing batch packets and ensure approved packets are available to Production within required timelines.
• Review completed batch order files, batch records, and receiving reports for required documentation, accuracy, completeness, and compliance.
• Verify critical batch record information, including expiration dates, work order numbers, lot numbers, and allergen identification.
• Perform applicable ERP quality transactions, product release activities, and authorized batch certification responsibilities.
• Coordinate final batch certification with the Marketing Authorization holder and maintain batch order records, release documentation, and quality logs.
• Identify and escalate batch record discrepancies, missing documentation, or potential compliance concerns before product release.
• Receive, route, track, and maintain Change Requests; coordinate review, approval, implementation, and documentation of approved changes.
• Update product checklists, route required actions, monitor outstanding change activities, and ensure approved revisions are finalized in the QMS.
• Scan, organize, file, archive, and maintain quality records according to record retention requirements.
• Maintain active Quality Assurance logs and provide requested log information to stakeholders.
• Respond to Customer Service requests for Certificates of Analysis, coordinating with the Quality Control Laboratory when necessary.
• Perform assigned work in compliance with cGMP, GDP, Quality Assurance SOPs, company procedures, and applicable regulatory requirements.
• Support inspection and audit readiness through accurate documentation, effective record management, and compliant work practices.
• Communicate documentation requirements, approval status, outstanding actions, potential delays, and quality concerns to stakeholders.
• Collaborate across departments, independently manage assigned responsibilities, document completed work, and identify process improvements.
• Participate in required technical and quality training and maintain proficiency in applicable systems and procedures.

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.
• 401(k) plan with employer matching contributions up to 4%.
• Gym membership reimbursement.
• Monthly allowance of Thorne supplements.
• Paid time off, volunteer time off, and holiday leave.
• Training, professional development, and career growth opportunities.

What This Job Offers

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