QA-Regulatory & Document Coordinator

QA-Regulatory & Document Coordinator

This is a full-time, non-exempt position that is responsible for day-to-day quality assurance and regulatory functions including dietary supplement labeling and marketing material review, certification management, and international export support including product registrations. This position is responsible for management of master manufacturing records, batch records, and other Good Manufacturing Practices (GMPs), Hazard Analysis of Critical Control Points (HACCP), Food Safety and Modernization Act (FSMA), and State Department of Health (DOH) records. Wage range $22-$26.

Supervisory Responsibilities 

This is not a supervisory position

Essential Job Responsibilities

  • Coordinates efforts in maintaining all applicable registrations and certifications (such as Bioterrorism, Non-GMO Project verification, Kosher, Gluten Free, DOH, and GMP).
  • Maintains bulk, Nutrex, and private label master files and ensures that interdepartmental communication of change occurs.
  • Assists with review of dietary supplement product labels, labeling, including marketing materials for regulatory compliance.
  • Supports new product development and international export efforts, through collection and organization of quality and regulatory files.
  • Maintains up-to-date component, ingredient, and product specifications, product tool kits, vendor specifications, testing agreements, and GMP Agreements.  
  • Manages the TMS Document Control System, implements upgrades, and provides trouble shooting and technical support. 
  • Maintains and updates cGMP Master Manufacturing Records and Batch Records and ensures that all records are appropriately retained and archived. 
  • Supports product release with Batch Record review and COA generation.
  • Organizes and audits GMP records, including but not limited to Non-conforming Product Reports (NCPR), Correction/Prevention Action Reports (CPARS), Customer Complaints /Specifications, Management of Change (MOC), Vendor Approval/Evaluation, Equipment Verification, Batch Records, Sanitation and Production Logs, Label revisions, product specifications, Vendor Management, Risk Assessment documentation. 
  • Maintains bulk, Nutrex, and private label master files and ensures that interdepartmental communication of change occurs.
  • Conducts Master File Management for New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) compliance.
  • Conducts daily GMP/HACCP walk-throughs and sanitation sign off.
  • Provides sales support for customer inquiries and documentation requests.
  • Assists with external audit preparation and serves as a back-up audit scribe.
  • Manages documentation for contract manufacturers, co-packers, and vendors.
  • Ensures that Vendor Management files are current and evaluations occur as scheduled. 

Other Duties  

  • Serves as the secondary Scribe in FDA inspections. 
  • Audits Quality Management System through periodic reviews of SOPs and controlled documents used in each Department.
  • Assists with interdepartmental document organization and retention.
  • Performs other duties that may be assigned.

Physical Demands

This position includes sitting at a computer for extended periods of time, as well as working in a laboratory standing at a bench. May include occasional lifting of up to 40 pounds.

Working Conditions

Work is primarily performed in an office environment. Occasional work in document archive trailer.

Minimum Qualifications

  • Bachelor’s degree or equivalent combination of work experience and education, preferred.  
  • Previous work experience with GMP standards in relevant industry is preferred. 
  • Proficiency with PC-based computer applications including Microsoft Word, Excel, and Outlook.
  • Excellent organizational, administrative and time management skills, as well as attention to detail.  
  • Preferred Certified Quality Improvement Associate through ASQ or equivalent organization.
  • Able to work independently as well as part of a team.
  • Strong verbal, written and interpersonal skills.  
  • Able to perform the essential functions of the position with or without reasonable accommodation. 

Management reserves the right to change this job with or without notice.

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