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 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