Manager , Clinical Quality Assurance Job

Employer Name: BiotechCrossing	SpiderID: 2346660
Location: Ridgefield, Connecticut	Date Posted: 7/7/2008
Wage:	Category: Biotech
Job Code:

Job Description:
Prepare clear and concise written reports of audit observations, including an assessment of compliance. Assess adequacy of auditees action plan. Conduct follow up activities as needed to monitor corrective actions. Participate in local initiatives involving GCP compliance, as assigned. Participate in meetings/teleconferences with International Clinical Quality Assurance group. Participate on ICQA working groups and projects as assigned. Maintain professional expertise and knowledge of local and international regulatory requirements. Assist with GCP training internally of Medical /DRA and externally of investigators and vendors. Provide guidance on GCPs and requirements surrounding computerized systems to Medical/DRA on daily basis as needed. REQUIREMENTS: BS/BA in scientific or health related field. Minimum of 8 years pharmaceutical industry experience. Six years auditing experience with minimum of 4 years specific to GCP auditing (CSV Specialist - 4 years specific to medical area) or 6 years as Senior level CRA with on site monitoring experience (CSV Specialist- 6 years of IT/validation experience).

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: BiotechCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com