Location: | Melville, NY, USA | Pay Rate: | $28.00 - $31.00 per hour |
Pay Type: | per hour | Employment Type: | Full Time |
Join our Natural Organics Inc / Natures Plus Family!
For more than 50 years, Natural Organics Inc. headquartered in Melville, NY has been the gold standard in natural vitamins and supplements. Marketing our products under the Natures Plus brand, we are committed to producing the finest, most effective formulations available. Our employees embody the true spirit of our Natures Plus brand. We have one goal...
Bringing you high-quality products with the guaranteed potency you deserve!
We are currently seeking a QA Specialist - Regulatory for our Melville, New York location.
Roles and Responsibilities:
The Quality Assurance Specialist - Regulatory is responsible for ensuring that NOI has in place documentation, procedures, and processes that ensure compliance with CGMP and HACCP requirements and regulations.
1) Review of product formulations and labels (and revisions thereof) for compliance with established guidelines and regulations.
2) Provide quality and regulatory related support in the creation, review, and execution of validations and qualifications of equipment and processes as required to ensure cGMP compliance.
3) Provide regulatory support as needed, i.e. review Certificates of Analysis prior to sending to customers/contract manufacturers, assist in the notification and preparation of documentation for products being shipped to both domestically foreign countries, etc.
4) Prepare and review compliant product specific White Paper documentation for each product developed by and manufactured at NOI. This includes outlining all testing performed for each product, providing written justification for each product's testing scheme, and coordination of document approval.
5) As directed, shall create, review, issue, and/or maintain, for compliance to regulatory requirements, other Quality and Operational documentation generated at the site. This may include documents such as, but not limited to, task instructions, audit records, equipment/instrument manuals, calibration and maintenance records, certificates of ingredients, label copy, and formulations.
6) Provide quality and regulatory related support to all departments to ensure that Standard Operating Procedures required for cGMP compliance are created, reviewed, issued, revised, and maintained in accordance with company procedures and policies.
7) Maintain, as per company procedures and policies, SAP, ETQ, and Formulator systems as they relate to the responsibilities herein.
Physical Requirements:
Standing and walking short distances for most of the day
Must be able to lift 10 lbs.
Qualifications:
Bachelors Degree in Pharmacy, Chemistry, or other related field
or 10+ years working directly in Pharmaceutical, Dietary or Nutritional Supplement, or a similar cGMP related industry.
Strong Documentation and Computer Application ability required.
Strong written and oral communication skills required.
Must be detail oriented and well organized.
Benefits: Competitive salary, Medical, Dental, Life Insurance, Aflac, Short- and Long-Term Disability, 401(k) with company match, Generous paid time off days and holidays, Opportunities for professional development and growth, Discounted vitamins and supplements,
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