What are the responsibilities and job description for the Quality Assurance Document Control Specialist position at Thorne?
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
THORNE IS AN EQUAL OPPORTUNITY EMPLOYER
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.
- High school diploma or general education degree (GED) is required.
- Identifies root causes instead of symptoms, asks thoughtful questions, and makes decisions based on facts and data.
- Quickly diagnoses problems by interpreting data, reviewing processes, and verifying assumptions before acting.
- Employee has knowledge of Microsoft products such as Word and Excel, as well as the ability to learn the ERP computer system as well as the document/ change management systems utilized at Thorne Research.
- Develops and delivers on assigned objectives within requested timeframes.
- Possesses good interpersonal skills, engaging with others in a positive manner.
- Possesses strong attention to detail.
- Possesses strong verbal and written communication skills.
- Raises issues and concerns promptly and brings pragmatic solutions.
- Documents and presents work in a clear, accurate, and concise manner.
- 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 and holiday leave
- Training, professional development, and career growth opportunities
THORNE IS AN EQUAL OPPORTUNITY EMPLOYER