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| Company: |
The Barron/Carlington Group |
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| Job Title: |
Sr Clinical Quality Specialist |
| Job category: |
Biotech |
| Job Location: |
Rochester - NY New York - USA |
| Job Reference Number: |
4465 |
| Job Description: |
4465 - Sr. Clinical Quality Specialist Location: Rochester, NY----Relocation Available / up to 25% Travel necessary
This is a Retained Executive Search, our client is a Major health products organization with the oldest, best known and most respected healthcare brands in the world. We are searching for a Sr. Clinical Quality Specialist If you are interest please forward your resume and I will respond back Asap.
Position Details
Salary Range: $70K - 95k
Us Citizen or Permanent Resident [Green Card Holder] only
Best Industry- Healthcare
Department : Quality Assurance , Research & Development
4 Year Degree
3- 5-years exp
Up to 25% Travel
Relocation Available - moving allowance of one (1) month’s salary.
Job Duties:
Support the Global Clinical Programs Clinical Quality and Document Control function with a primary responsibility for conducting internal and external audits.
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.
Special Skills:
Expert organizational, written and verbal communication skills and the ability to present with a professional and diplomatic approach are required for this role.
Specialized Training:
Extensive knowledge of GCP regulations/guidelines and Privacy regulations worldwide, as they pertain to clinical research and a good understanding of drug and device clinical trial development processes and clinical monitoring practices.
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. |
Language Requirements: |
English-Very Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
85000 USD |
| Posting Date: |
2008-07-22 |
| Level of Education: |
Bachelor |
| Years of Work Experience: |
3 to 5 Years |
| Company: |
The Barron/Carlington Group |
| Contact Name: |
The Barron/Carlington Group |
| Contact Phone: |
2126431111 |
| Preferred Method of Contact: |
E-mail |
| Preferred Language of Resume/Application: |
English |
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