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Quality Assurance Specialist 1

4 months ago

West Lafayette, United States Cook Group Full time

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 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