Quality Assurance Auditor Job

Employer Name: Rho, Inc.	SpiderID: 2222308
Location: Chapel Hill, North Carolina	Date Posted: 5/13/2008
Wage:	Category: Biotech
Job Code: 00254
Number Of Openings: 1

Job Description:
Scope:
The Quality Assurance Auditor performs QA audits under the direction of the Director and Assistant Director of Quality Assurance. Responsibilities include writing audit plans and reports, assisting with evaluating compliance with company procedures, policies, programs, and initiatives as well as GCP and regulations. The QA Auditor may also be required to perform other duties within the Quality Assurance Department.

-Maintaining an internal audit calendar
-Developing plans for, conducting, and reporting on internal audits
-During the conduct of internal audits, evaluating various aspects of compliance by operational units with regulations and GCP
-Reviewing software and systems validation documentation
-Auditing operational units’ study conduct and systems to ensure compliance with internal and applicable sponsor process documents (SOPs, Guides, MOPs, and study specific documents)
-Scheduling for and reviewing QC and tracking logs throughout Rho
-Communicating compliance issues
-Assisting operations staff in the resolution of quality issues and the development of action plans to correct deficiencies
-Assuring the efficient implementation of corrective action plans
-Developing regular reports for tracking quality assessments
-Conducting vendor qualification and maintenance audits
-Assisting in the management of the organization and preparation for an audit by corporate clientele or a federal agency
-Conducting GCP investigational site audits, including audits of case report forms, source documentation, study materials and facilities
-Conducting Trial Master File audits
-Assisting in the management of the response to or remediation of an audit
-Assisting in the management of procedural documents
-Develops training materials

Job Requirements:
Basic Qualifications
-Minimum five years of experience in quality assurance or at least seven years experience in drug development.
-Bachelor’s degree in life sciences, social sciences or liberal arts discipline (or related area of study) or equivalent combination of education and experience.

Knowledge, skills and abilities
-Ability to adapt to changing work priorities
-Attention to detail
-Knowledge of ICH, GCP and relevant regulations
-Ability to work independently
-Ability to direct others
-Working knowledge of regulatory documents is required.

Preferences
-Certification in clinical research, regulatory affairs, or auditing is preferred (CCRP, RAC, etc.), but not required.

To apply for this position, please go to http://www.rhoworld.com/hr and apply through our corporate web site. Resumes will not be accepted through any other vehicle.

Rho, Inc. is an Equal Opportunity Employer.

Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 5
Education Required: Bachelors
Overnight Travel: None
Vacation Time:

Job Benefits:
Health/Dental Benefits, Retirement Benefits, Paid Holidays, Vacations, and Sick Leave, Life and/or Disability Insurance, Flex Time, Tuition Reimbursement, Casual Dress

Company Profile:
Rho, Inc. is a Chapel Hill, NC based CRO. Our employees drive and maintain the culture our owners set out to create over 20 years ago: a team based environment rich with diversity. Rho, Inc. employees are quality and service oriented and eager to work together to get the job done - and they have fun while they’re doing it! If you’re looking for a company that embraces diversity and rewards hard work, look no further and apply with Rho.

Carolina Parent Magazine’s Top 40 Family-Friendly Workplaces. To find out more about Rho, please visit http://www.rhoworld.com.

Rho, Inc. is an Equal Opportunity Employer.

Contact Information:

Contact Name: Marc Witorsch	Company Type: Employer
Company: Rho, Inc.

City: Chapel Hill
State: North Carolina
Zip: 27517

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