Label Compliance Specialist

Provident Nutraceutical a division of Ortho Molecular Products
Job Description
Would you like to work with professionals who are highly motivated and believe in teamwork and have tremendous growth potential? We are currently seeking a Label Compliance Specialist to work in our Stevens Point plant. The incumbent is responsible for managing and reviewing new and revised product label development according to the requirements under 21 CFR 101.36, the electronic development and management of product labels, including but not limited to primary package, dispenser cartons, shipping labels and instructions for use. The Label Developer is responsible to coordinate the collection of required approvals, ensure the accuracy of label content, revision control, and maintenance of complete records which are subject to FDA inspection.
Provident, a Division of Ortho Molecular Products, is a leading manufacturer of dietary supplements.  With nearly 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 team members.
  • Manage label development and revision program to ensure compliance to 21 CFR 101.36.
  • Review and update finished good labels according to 21 CFR 101.36.
  • Develop Supplement Facts Boxes for new and existing products according to 21 CFR 101.36.
  • Perform Quality review of label proofs and approve final proof
  • Provide assistance to Marketing, Sales, and R&D regarding label development and modification.
  • Become efficient with the Navision operating system as it pertains to label version control and label information.
  • Become efficient with the Belmark label proof approval system
  • Perform request for change analysis on changes required to labels.
  • Perform duties in compliance with SOP’s and GMP’s.
  • $15.50/hr-$16.50/hr (depending on experience)
  • 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
  • Degree in a related Quality compliance field and/or 2-4 years’ experience in related field required.
  • Basic knowledge of quality systems and/or quality auditing.
  • Basic knowledge of Good Manufacturing Regulations.
  • Proficient in the Microsoft Office Suite (includes Word, Excel, Access and PowerPoint); experience in SharePoint, Adobe Illustrator, and ERP systems desired.
  • LANGUAGE SKILLS:  Ability to read and comprehend instructions, memos, emails, SOP’s 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. 
  • MATHEMATICAL SKILLS:  Ability to add, subtract, and multiply applying statistical mathematical concepts when needed.
  • REASONING ABILITY:  Ability to apply common sense understanding and carry out instructions furnished in written and oral form.
  • PHYSICAL DEMAND:  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. Infrequent lifting may be required up to 50 lbs.
  • WORK ENVIRONMENT: 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 wellbeing of our employees.  We are a tobacco-free campus.  There is no smoking or tobacco use of any kind in any of our buildings including our parking lots.  If you want to smoke or use tobacco products, you need to leave our company premises.  This applies to our employees and any visitors.
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