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Under the guidance of the Document Control Manager, the Compliance Specialist is directly responsible for maintaining a high-level of Quality, compliance and consistency of records, procedures, and regulatory submissions. He/she will provide document maintenance and editing, facilitate compliance reviews and approvals, aid in document control solutions, and support the Document Control Manager as required with all compliance related and document control tasks.
Responsible for working with internal and external customers and the Document Control Manager to create, review, revise, and controls of documents. Examples include design and process definition, training documents, and regulatory documents.
Responsible for tracking and communicating issues related to compliance and document control related issues to document control manager.
Responsible for ensuring internal customer support and development of solutions to internal compliance and document control related issues along with Document Control Manager.
Education Required: High School Diploma or Equivalent
Work Experience Required:
Minimum of 1 year working in quality, document control, regulatory position or similar position e.g. quality inspector.
Extensive use of Microsoft Office.
Detailed oriented with the ability to contrast outputs versus requirements accurately
Strong and experienced skill set within Microsoft Office, examples include creating spreadsheets, document creation, revision and review.
Customer and timeline focused
Experience working within a regulated industry such as personal protective equipment, automotive, aerospace, medical device, or pharmaceuticals, and experience or knowledge of regulations or standards (e.g. EN, ASTM, or ISO) is preferred.