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QUALITY ASSURANCE DOCUMENT CONTROL SPECIALIST- 3pm-11:30pm

4 months ago

Summerville, United States Thorne Research Inc Full time
Job DescriptionJob Description QUALITY ASSURANCE DOCUMENT CONTROL SPECIALIST-Monday-Friday 3pm-11:30pm


At Thorne we make products that matter - ones that make people's lives better. 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 650 passionate individuals committed to our cause of providing superior health solutions.

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.

RESPONSIBILITIES – Satisfactorily performing and/or achieving the following Responsibilities are essential duties of the job.

  • 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.
  • Knows and follows the Quality department policies and procedures and Thorne Research policies and procedures as outlined in Thorne Research’s Employee Handbook.
  • Pays attention to detail. Employee completes paperwork accurately, neatly, and completely.  Willingly works in different areas as assigned.
  • Gets along with co-workers and supervisors. Employee responds appropriately to criticism and instructions from supervisors. Employee follows the Standards of Conduct as outlined in the most current version of Thorne Research’s Employee Handbook.
  • Takes initiative to make sound decisions within the guidelines provided, is consistent in their work, and sees projects through to a satisfactory end without supervision.
  • Demonstrates initiative and job knowledge by suggesting ideas, discovering new and better ways of accomplishing goals and finding innovative, well thought-out solutions to problems.
  • Seeks formal and informal performance assessments of self, including performance versus expectations and goals, behaviors, and leadership potential.
  • Promotes the Company’s Mission and Values, including an accountable, innovative, and results-oriented culture encouraging customer service, openness, teamwork, mutual trust, and respect.
  • Actively participates in all required training and development programs and electives.
  • 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).
  • 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

What You Need:

  • Experience and/or Education: By training, education and/or experience, employee must be able to perform the essential duties of the job. High school diploma or general education degree (GED) is required.

What We Offer:

At Thorne, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, such as:

  • Competitive compensation
  • 100% company-paid medical, dental, and vision insurance coverage
  • 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
  • A safe and clean work environment

A little bit more about us.

We are committed to providing personalized health solutions, cutting-edge home health test technology, and superior supplements. To do that, Thorne owns every step of its business, from R&D to product delivery and customer service. Currently, we are:

  • The only company with exclusive partnerships with the Mayo Clinic and U.S. Olympic teams.
  • The #1 prescribed practitioner brand to 30 to 40-year-olds.
  • The #2 most dispensed supplement brand.
  • The fastest growing supplement company with sales on Amazon; the #1 practitioner brand; with an average ranking of 4.42 of 5 stars.

If you want to make a difference in the lives of others consider becoming part of the Thorne team.

“Please be advised that Thorne Research manufactures nutritional supplement products that can include ingredients that are derived from possibly allergenic raw materials, including but not limited to nuts, soy, dairy, fish, and shellfish.”

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER