Quality Assurance Specialist 1 - West Lafayette, United States - Cook Group

Cook Group
Cook Group
Verified Company
West Lafayette, United States

2 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Overview:

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 closelyrelated 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
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