Quality Assurance Document Control Specialist

At Thorne, we work to deliver high-quality, science-backed solutions to empower individuals to take a proactive approach to their well-being. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. At Thorne, you'll be joining a team of more than 750 passionate individuals committed to our cause of providing superior health solutions at every age and life stage.

Position Summary : The Quality Assurance (QA) Document Control Specialist is responsible and accountable for all aspects of document control. Document control includes, but is not limited to, the maintenance of procedures, forms, specifications, work instructions, formulas, master manufacturing records, and any other controlled documents, and quality record control and maintenance.

This position is for Tuesday - Saturday, 8am - 4 : 30pm

Responsibilities

• Knowledgeable of and follows the applicable provisions of the QA department's standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMPs). Employee remains knowledgeable on an ongoing and timely basis as changes in the SOPs and cGMPs occur.
• Pays attention to detail. Employee completes paperwork accurately, neatly, and completely.
• Scans, files, and maintains all quality records per the record retention policy.
• Responds to emails in a timely and professional manner.
• Maintains and updates all active QA logs and issues appropriate log info as needed.
• Creates and reviews batch packets to be used for manufacturing of products.
• Verifies all job cards have approved packets sent to production in a timely manner.
• Understands and is competent in conducting quality transactions in the ERP system (e.g., release of product).
• Ensures completed and released batch order files contain all necessary documentation. Verifies batch record is correct / product is ready to be released for sale, as well as updating logs and pulling and / or filing completed batch orders. Ensures all appropriate information is correct within the batch record (e.g., expiration date, work order number, lot number, allergen stickers, etc.).
• Conducts batch record and receiving report review to determine final disposition of product. Ensures good documentation practices within quality records and documents.
• Conducts release of product that meets specification utilizing the ERP system.
• Acts as an Authorized Person to certify that each production batch has been produced and controlled in accordance with the requirements of the Marketing Authorization and any other regulations relevant to the production, control and release of medicinal products.
• Receives, routes, and tracks Change Requests through the Quality Management System. Implements approved changes and maintains the Change Request records through the Quality Management System
• Updates and completes steps in all relevant product checklists and routes to respective personnel for implementation and completion.
• Creates, formats, edits, routes, finalizes, files, and maintains all controlled documents within the Quality Management System. Coordinates with Subject Matter Experts (SMEs) to ensure document accuracy.
• Ensures periodic document reviews are conducted per allotted time frames.
• Provides support in answering questions about Quality Management System processes relating to Change Management and Document Control.
• Troubleshoots and provides solutions to issues during the change management process.
• Works with Management, SMEs, and other department heads to ensure training is documented for all applicable employees before documents revisions are released.
• Ensures all tasks for finalization of controlled documents are completed (SOPs, forms, WI, policies) in the Quality Management System.

What You Need

What We Offer

Thorne is the leader in science-backed health and wellness solutions committed to helping individuals live healthier longer. As the top recommended clinical brand by healthcare practitioners, Thorne offers a comprehensive range of products including nutritional supplements and health tests designed to meet the unique needs of individuals at every stage of life. Founded in 1984, Thorne products are formulated with the highest-quality ingredients, supported by clinical research, and rigorously tested to ensure purity, potency, and efficacy. Thorne is trusted by 47,000+ health-care professionals, thousands of professional athletes, more than 100 professional sports teams, multiple U.S. National Teams, and more than five million consumers. For more information, visit Thorne.com.

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

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