QA Document Control Specialist

Thorne Summerville , SC 29484

Posted 1 week ago

QA Document Control Specialist

We are looking for top of market talent to help grow and innovate our company. If you are someone who embraces challenge, fosters innovation, and desires to make a difference in the world, then let's talk.

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. As a self-motivated QA Document Control Specialist you'll be joining a team of more than 350 passionate individuals committed to our cause of providing superior health solutions.

Thorne's 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.

A day in the life of a QA Document Control Specialist at Thorne requires that the employee:

  • Is 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.

  • 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.

  • Files and maintains all quality records.

  • Responds to requests for documents and provides documents in a timely manner.

  • Maintains and updates all active QA logs/QA databases and issues appropriate log/database info as needed.

  • Works with assigned departments to create, route, review, and file reports.

  • 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 (expiration date, work order number, Thorne ID, allergen stickers, etc.).

  • Verifies the labels received match the current specification. Updates Label Review Log and provides copies/info as needed.

  • Receives, routes, and tracks Change Requests. Implements approved changes and maintains the Change Request records.

  • Updates New Product/Material Checklist and routes to respective personnel for implementation and completion.

  • Creates, formats, edits, routes, finalizes, files, and maintains all controlled documents. Coordinates with Subject Matter Experts (SMEs) to ensure document accuracy.

  • Assist with ongoing implementation tasks related to ERP system, including form revisions and continued testing and system verification.

  • Populates, updates and controls the critical data in Quality databases.

  • Works with Management, SMEs, and other department heads to ensure training is documented for all applicable employees before documents revisions are released.

  • Ensures all necessary steps are completed on the Product Discontinuation checklist including notification to all necessary departments.

  • Ensures all tasks for finalization of controlled documents are completed (SOPs, forms, WI).

  • Ensures periodic quality reviews are completed in a timely manner.

Employment is contingent on satisfactory results from a drug screening, background and reference checks.

What You Need:

  • High school diploma
  • 3 years' related experience

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.

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER


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