Internal Auditor

Posting Date 3 weeks ago(11/10/2022 11:47 AM)
Requisition ID
2022-11878
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Quality

Overview

This position is a Cook Biotech Inc. Compliance Specialist whose job it is to manage and maintain evidence of compliance to regulations.

Responsibilities

  • Responsible for the performing of Internal Audits based on the audit schedule. , Generates and manages audit records from initial audit meeting to audit closure.
  • Assist in determining suitability of auditee responses.
  • Assists with regulatory and partner audits
  • Assists with responses to external requests (i.e. Audit Questionnaires) and Supplier Corrective Action Requests(SCAR).
  • Assist in meeting Corporate and Quality System goals

Knowledge:

  • Understanding of application of regulatory requirements per FDA Quality System Requirements, ISO 13485, MDSAP, EUMDR and other relevant regulations
  • Team Dynamics:
  • Works well with local team Change / Innovation:
  • Proposes ideas
  • Decision Making:
  • Consults peers and supervisor for decisions.
  • Able to work with multiple persons and the multiple priorities that occur when each person has different needs
  • Computer skills including word processing, data base, and spreadsheet programs
  • Strong attention to detail
  • Strong organizational and prioritizing skills

Qualifications

    • Must be able to perform the essential functions of the job
    • Limited exposure to hazardous chemicals used in the manufacture of the product
    • Physical demands are typical of an office and classroom environment
    • Sign non-competition and confidentiality agreements. Compliance with all policies of the company including without limitation the COOK Employee Manual, COOK Code of Conduct, COOK Electronic Information Policy, HIPAA regulations, and COOK Policy & Guidance on Interaction with Healthcare Professionals.

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