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Regulatory Compliance-Document Specialist

Harrison, NY
Currently looking for a Regulatory Compliance/Document Specialist to fill an opening with a company located in Harrison, NY. Interested candidates must hold a Bachelor’s degree and have knowledge of regulatory documents, COA, product quality documents, FSMA, SCARS, CAPA,FDA.

Responsibilities of the Regulatory Compliance/Quality Control/Document Specialist: 
·  Product Document Request
o   Receive / Follow up with Customer for product document statements/questionnaires
o   Request / Follow up with Manufacturer for product document statements/questionnaires
o   Organize / rename documents on shared drive
o   Obtain updated Certificates from manufacturers on file
·       Assist with projects
o   Sourcing
o   Run weekly inventory reports for the sales reps.
·       Complete Vendor Questionnaires from customers
·       Receive current customer raw material specifications and work with the manufacturer to comply with the revisions if possible
·       Work with independent analytical testing laboratories
o   Extend the shelf life of material on COA
o   Additional testing results requirements from the customer regarding products
·       Complete any SCAR Reports if necessary
·       Compile Certificates of Analysis Reports for company products
·       Other duties may be assigned as needed including but not limited to answering phones, filling in for employees while they are out, filing, etc.
·       Assist in keeping the company compliant with industry/government regulations
 

Requirements of the Regulatory Compliance/Quality Control/Document Specialist: 
 
·       College Degree
 
         Knowledge of regulatory documents, COA, product quality documents, FSMA, SCARS, CAPA,FDA
 
·       Microsoft Office
·       Team Player
·       Detail Oriented
 
PY
 
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