Quality Specialist

3 weeks ago
Requisition ID
2017-3268
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 team.

Responsibilities

• Ensure that the quality policy and quality system are maintained and implemented at all levels of the organization

• Review and approve protocols, reports, project documentation, validation documentation, and regulatory submissions for accuracy and compliance to applicable procedural standards and Standard Operating Procedures

• Ensure Quality Management Systems (QMS) procedures are compliant with regulations and standards

• Assess impact of proposed procedural changes

• Perform project inspections

• Train staff on QMS processes

• Report quality 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 must include: ISO 13485; ISO 17025; Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards; auditing; and MS Office Software (Word, Excel, Visio, PowerPoint, Project)

• Must have current authorization to be employed in the U.S. without employer sponsorship

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