Cook Group

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 teh 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;

Ability to multi-task and work across departments with multiple stakeholders; and 

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 (e.g. 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 (e.g., H-1B or TN status) for this employment position