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Browse the latest offers of Work by Category »  Biotech Jobs » USA
Job Details
Company: The Barron/Carlington Group
Job Title: Sr Clinical Quality Specialist
Job Category: Biotech
Job Location: Rochester - NY New York - USA
Job Ref. Number for your records: 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.
Skills Required:
Language Requirements:
  • English-Very Good
  • Employment Type:
  • Full Time
  • Yearly Salary: 85000 USD
    Posting Date: Jul 22 2008
    Education & Experience
    Education level required: Bachelor
    Experience (in years): 3 to 5 Years
    Contact Information
    Company: The Barron/Carlington Group
    Contact Name: The Barron/Carlington Group
    Contact Phone: 2126431111
    Preferred Method of Contact: E-mail via Apply Online Box
    *** Apply for this Job Here ***
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