Halo Pharmaceuticals

Quality Auditor

US-NJ-Whippany
Type
Regular Full-Time

Overview

Quality Assurance Auditor is an extension of the Regulatory Compliance Department within the Quality Assurance umbrella, responsible for internal, regulatory and vendor audits.  This includes performing audits and audit risk assessments in order to evaluate the compliance impact of new suppliers.  Perform routine audits of internal departments against international and domestic compliance and cGMP requirements.  Drive the completion and closure of Corrective Actions and Preventive Actions as they pertain to internal and external audit findings.  Report Quality Metrics as they pertain to the Regulatory Compliance Department.

 

This position will serve to support client and regulatory audits, host audits, run the “War” room during compliance audits (as applicable) and support strategic compliance objectives.

 

Responsibilities

ESSENTIAL FUNCTIONS

  • Schedule and conduct audits of vendors, contract service providers, and internal departments.
  • Prepare audit agendas, respond to client / regulatory observations and generate audit reports.
  • Determine if a third party facility is GMP compliant.
  • Provide follow-up, status updates and / or regulatory communication response / notification to various regulatory bodies.
  • Perform regulatory impact assessments for proposed process / product Change Controls and vendor change notifications.
  • Send audit questionnaires to selected vendors and follow-up on responses.
  • Perform vendor risk assessments and obtain vendor quality agreements.
  • Maintain and update approved vendors and contract service providers lists.
  • Work with other departments including Product Development, Purchasing, Warehouse, Quality Assurance, and Planning to assure that vendors are approved and able to be utilized.
  • Support the regulatory / compliance aspect of the import / export of products and chemicals.
  • Provide assistance for on-site customer audits and regulatory inspections.
  • Provide facility tours
  • Other duties as assigned

Qualifications

POSITION QUALIFICATIONS

  • Must be well organized and detail oriented
  • Ability to set priorities and work in a fast-paced environment is required
  • Travel - 10%

EDUCATION:  

  • 4 year degree - Science Major

EXPERIENCE:

  • 3+ years with industry experience (within the Pharmaceuticals, Diagnostic, or biotech industries)

 

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