Sr. Clinical Quality Specialist - (US-NY-Rochester)
Sr. Clinical Quality Specialist - (US-NY-Rochester)
Compensation: $70K - $85K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: B4465JA
Experience Required : 3 - 5 years
Degree Required : 4 Year Degree
Travel Required : to 25%
PAID RELOCATION AVAILABLE
Support the Global Clinical Programs Clinical Quality and Document Control function with a primary responsibility for conducting internal and external audits.
Job Duties:
Conduct external and internal comprehensive audits and document reviews independently and effectively in compliance with department SOPs.
During audits, gather information and evaluate processes against applicable regulations (FDA, HIPAA, etc.), SOPs and policies, company business needs and other applicable standards.
Distinguish between relevant and irrelevant facts to provide accurate and timely audit reports with recommendations for resolution; follow all major and critical findings to completion of resolution.
Support department training and SOP development needs.
Support department management when hosting FDA inspections.
Candidate Must Have :
* Bachelor's degree preferably in biological or medical sciences
* Five years experience in a compliance, regulatory or clinical environment, preferably with at least 2 years Good Clinical Practices audit experience.
Email resume in Word to thebiggamehunter@cisny.com. Please include the job code for the position with your resume.
NO RELOCATION. NO VISA TRANSFERS. NO OVERSEAS RESUMES. NO 3RD PARTIES.
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