Job Title: Quality Assurance Auditor (GCP)
Date Posted: 09-18-2007
Job Location: Pennsylvania-Philadelphia
Job Type: Full Time
Education Level: Masters Degree
Work Experience: 2+ to 5 Years
Job Shift: First Shift
Yearly Salary:DOE (Depend on Experience)
Company Name: Barr Laboratories, Inc
Company Website: www.barrlabs.com
Contact Information: Barr Laboratories, I   Barr Laboratories, I (rdcareers@barrlabs.com)
Job Description:
Description: 
 Ensure that Barr Research processes, procedures and activities are in compliance with GCPs
and other prevailing regulations and guidances.
 Conducting and/or overseeing audits of internal procedures, clinical study reports, CROs,
clinical investigators, contract labs, SOPs and outside vendors
 Providing CQA representation to project teams
 Assisting in the creation and maintenance of CQA SOPs and audit tools
 Investigating and resolving compliance problems and questions regarding Regulatory Affairs,
Clinical Operations, Data Management, Statistics, and Safety
 Conducting GCP Training
 Assist with hosting regulatory agency inspections
 Other Duties as assigned

Requirements: 
 MS/BS degree in Scientific Discipline/ Life Sciences
 3-5 years experience in Clinical Quality Assurance
 Thorough knowledge of Good Clinical Practices (GCPs), quality systems (SOPs) and audit
procedures and reporting
 Applying principals of 21 CFR Part 11 to clinical systems
 Capable of writing effective SOPs, Quality Assurance Reports and training materials 
 Ability to communicate effectively and non-confrontationally with internal departments
 Ability to multi-task; to develop systems and SOPs while reviewing protocols and report
 Capable of planning activities to meet CQA objectives 
 Ability to resolve / document quality problems as appropriate and know when to elevate
problems to a higher level
 Responsible for conducting GCP compliance activities for Barr Research, Inc.
 Ability to travel 30-50% of the time

Barr Laboratories. Inc offers competitive salaries and a comprehensive benefits package
including a stock purchase plan and a 401(k) plan with a generous company match.
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