US-NJ: Princeton-Sr. Auditor (QA&C)

**************************************************************
JobCircle.com is a regional job board serving all industries
and occupations in the PA, NJ, DE, NY, MD, and DC areas.

We offer a regional job board, online learning, and regional
job fair events for jobseekers who live in our areas of focus.

To Learn More:

Job Board: http://www.JobCircle.com?source=ng
eLearning: http://www.JobCircle.com/courseware?source=ng
Job Fairs: http://JobCircleJobFairs.com?source=ng

**************************************************************

Job Title: Sr. Auditor (QA&C)
Job Location: NJ: Princeton
Pay Rate: $60-100 p/h
Job Length: temp-to-perm
Start Date: 2008-08-25

Company Name: Technology Services, LLC
Contact: David V. Majeski
Phone: email or fax only
Fax: 856-234-9983

Description: Temp-to-perm position in Princeton, NJ for a Sr. Auditor. Position requires 50% travel -US and Canada accounts for 90% of the travel. Position is available immediately.


Business Title
Senior Auditor, QA&C

Job Category
Quality

Locations
USA - Princeton, NJ

Shift
1

Job Description
Job Duties and Responsibilities:
- Auditing
- Act as a Lead Auditor
- participate in audits, as assigned, according to applicable SOP(s) and the project Quality Plan
- identify non-conformances with requirements and provide suitable recommendations
- assure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management
- ensure suitable responses and action plans provided by auditees
- serve as a backup auditor to other QA&C staff
• Special Projects
- participate in QA projects
- support special projects requiring QA input
• Quality Assurance
- contribute to process improvement initiatives across organization
- develop and maintain global quality system to recognized standards
- participate in development of QA processes and SOPs
- support development of processes and SOPs by process owners outside QA
• Liaison / Representation
- represent QA on project teams, and other internal forums
- represent QA at client meetings and/or audits

Education/Qualifications
Education / Qualifications
Required
• University/college degree (life science preferred)
• Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
• Financial understanding of global clinical development budgets
• Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
Preferred
• BA/BS or equivalent experience
• Knowledge of the drug development process from the perspective of a contract research organization

Experience
Required
• Minimum of three (3) years experience in the pharmaceutical/CRO industries, with at least two (2) years in Clinical Quality Assurance, preferably within a GCP environment
• Strong analytical skills
• Knowledge, understanding and experience in applying ICH/FDA Good Clinical Practices
• Excellent oral, written and presentation skills
• Excellent planning and organizational skills
• Proven interpersonal skills
• Demonstrated ability to handle multiple competing priorities across clinical operating units
• Ability to function as a member of a global clinical team

Please refer to Job code SA-NJ when responding to this ad.


For FASTEST PROCESSING of your resume, please visit http://www.jobcircle.com/classifieds/1637252.html?source=ng to apply online.


**************************************************************
For fastest processing of your resume, this employer asks that
you apply to this job using the URL above.
**************************************************************