What are the responsibilities and job description for the Quality Assurance Document Control Specialist - Entry Level position at Thorne?
Department: Quality Assurance
Location: Summerville, SC
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.
This position is for 2nd shift, Tuesday - Saturday, 3pm - 11:30pm
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.
RESPONSIBILITIES
- 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.
- Responsible for final batch certification together with the Marketing Authorization holder to ensure that the quality review is performed in a timely manner and is accurate.
- 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.
- Responds to Customer Service requests for Certificates of Analysis (C of A) and works with QC laboratory to obtain C of A if not already included in batch order file.
- 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).
- High school diploma or general education degree (GED) is required.
- Employee has the ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- 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.
- Employee has the ability to add, subtract, multiply, and divide in the units of measurement used in the Quality department, using whole numbers and decimals.
- 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