Overview

Cook Research Incorporated is currently accepting applications for a Quality Assurance Specialist 1 to become a part of our growing Quality Assurance team.

This position is responsible for assuring that the quality policy and system are maintained within the organization.

Responsibilities

• Review and inspect protocols, reports, project documentation, data, and regulatory submissions for accuracy and compliance to applicable procedures, standards, and regulations;
• Ensure QMS procedures are compliant with applicable regulations and external standards;
• Assess impact of proposed procedural changes to CRMS and other related documents;
• Maintain a working knowledge of CRMS processes and procedure, regulations, and standards;
• Act as a Quality consultant for processes;
• Train staff on CRMS processes;
• Comfortable working in collaborative and independent work situations;

May participate in internal audits - Auditing Certification is of advantage.

Qualifications

• Associate’s degree in Engineering, Physical or Life Science field, or closely-related technical field preferred;
• One (1) year of experience in a regulatory environment within the medical, biotechnical, or pharmaceutical industry;
• Experience in a regulated environment preferred (. ISO 13485; ISO 17025;
• Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards; and
• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (.

H-1B or TN status) for this employment position

Last updated : 2024-06-22