Quality Assurance Specialist 1

2 weeks ago


West Lafayette Indiana, United States Cook Group Full time
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

 



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