Quality Specialist

Posting Date 2 months ago(7/26/2021 2:09 PM)
Requisition ID
2021-9338
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Research Inc.
Category
Quality

Overview

 Cook Research Incorporated is currently accepting applications for a Quality Specialist to become a part of our growing Quality Assurance team.

Responsibilities

• Ensure the Management System and Quality Policy are maintained and implemented

• Inspect process deliverables (e.g. protocols, reports, project documentation) for accuracy and compliance to applicable procedures and regulations

• Ensure Management System procedures are compliant with regulations and standards

• Assess impact of proposed procedural changes

• Train staff as needed

• Report issues to management

Qualifications

• Bachelor’s degree in Engineering, Physical or Life Science field, or closely-related technical field

• One (1) year of experience in a regulatory environment within the medical, biotechnical, or pharmaceutical industry

• Experience in a regulated environment preferred (e.g. ISO 13485; ISO 17025; Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards; 

• Qualified candidates must be legally authorized to be employed in the United States.  Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

 

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