Regulatory Documentation Coordinator

Provident Nutraceutical a division of Ortho Molecular Products
Job Description
Here at Ortho Molecular Products, we’re searching for a Regulatory Documentation Coordinator for our Stevens Point location.  The Regulatory Documentation Coordinator assists by maintaining the company’s regulatory documentation in compliance with state, federal, and international regulations, verifying compliance to Good Manufacturing Practices (GMPs), guidelines and applicable Standard Operating Procedures (SOPs).  The incumbent also ensures a state of control for executed and/or master documents within the requirements of all applicable regulations and industry standards.

Duties:
  • Coordinate the maintenance of regulatory documentation such as the Food and Drug Administration (FDA) Food Facility Registration, WI Food Warehouse License, and Certificates of Free Sale.
  • Coordinate the day-to-day operation of initiation, review, follow up, completion, issuance, and retention of controlled documents (e.g. Certificates of Composition, Certificates of Analysis, and general reports) to maintain regulatory compliance, quality approval, and/or register/license products.
  • Coordinate compliance reviews and approvals of new and revised literature.
  • Execute process for substantiation of structure/function claims for dietary supplements, maintenance of supporting documentation, and notification to FDA.
  • Serves as primary liaison between Business Affairs and Quality for contract manufacturing inquiries.
  • Monitor regulatory trends and industry standards.
  • Draft, revise, and review SOPs for the controlled documents and record
  • Creates document templates, format,
  • Perform duties in compliance with SOPs and
  • Stay current with GMP and other regulations that apply to the manufacturing, packaging, holding, and distribution of manufactured products.
  • Help design/implement systems and processes to meet regulatory compliance, as
  • Provide input and participate in projects, team meetings, and improvement
  • Evaluate compliance issues and recommend remedial actions required.
  • Assist in hosting all regulatory agencies and customers performing audits.
  • Support product label compliance with regulatory obligations.
  • Review procedures or specifications that impact the identity, strength, quality, and purity of the finished product. This includes generating and/or reviewing applicable SOPs.
Qualifications:
  • BS/BA in a related Science field and/or Regulatory Sciences
  • 1-2 years of regulatory compliance experience and/or training education equivalent combination of experience. TGA, EU European Union, and Health Canada experience preferred.
  • Experience in a cGMP FDA regulated manufacturing facility preferred.
  • ASQ certification, Six Sigma Green Belt, and/or Black Belt highly desired.
  • Proficient in the Microsoft Office Suite (includes Word, Excel, Access and PowerPoint); experience in SharePoint and ERP systems desired.
  • Ability to read and comprehend instructions, memos, emails, SOPs and other materials required. Ability to write legible correspondence.  Ability to effectively present information verbally to other employees of the organization. Must effectively demonstrate the ability to communicate in English, both verbally and in written format. 
  • Ability to add, subtract, and multiply applying statistical mathematical concepts when needed.
  • Ability to apply common sense understanding and carry out instructions furnished in written and oral form.
  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is required to sit, stand, walk, lift and talk or hear.  The employee is required to use hands to finger, handle, or feel objects, or controls; reach with hands and arms.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The noise level in the work environment is usually moderate to quiet.
  • Tobacco Free Campus: Ortho Molecular Products, Inc. cares about the health and well-being of our employees. We are a tobacco-free campus. This applies to our employees and visitors.
Benefits:
  • Health and dental insurance
  • Voluntary benefits (accident insurance, disability insurance, vision insurance, etc.)
  • 401(k) with company match
  • Bonus Opportunities
  • Corporate wellness program
  • Gym membership
  • Ample paid time off
  • Opportunity for growth


Ortho Molecular Products is a leading manufacturer of dietary supplements.  With 30 years of stability and growth, we are a leader in the industry.  Watch our company videos and learn more about our company values, culture and why Ortho is a great place to work.

Stop working a job and start your career with Ortho Molecular Products.  Apply today!



 
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