Quality Assurance Analyst

Pittsburgh  ‐ Onsite
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Keywords

Description

My client Is a world leader in the conduct of clinical trials and equivalency studies for the generic, pharmaceutical, and biotechnology industries.

You Carrie out various Quality Assurance and Regulatory Affairs activities independently. These activities ensure compliance to company SOP's, client and regulatory agency requirements.
Responsibilities:

· Manage staff in QA Manager absence.

· Assist QA Manager in scheduling workload for QA staff.

· Prepare checklists for use by QA Analyst and QA Specialist for review of Study Documentation, Regulatory Binders, etc.

· Review Regulatory Packets and Regulatory Binders.

· Review Protocols vs Guidances, Regulations, similar study protocols, Novum SOPs.

· Review final reports vs. protocol, study box and Sponsor-specific requirements/Regulatory requirements for reporting.

· Review validations.

· Assist QM with preparing for and hosting client visits.

Qualifications:

· Bachelor's degree (B.A.) from a four year college or university or equivalent related professional qualification such as RN, plus four or more years related experience in clinical research or QA assurance in a similar field

· Knowledge of spreadsheet, internet and word processing software.

Please send over your resumer to if interested and we will contact you.

To find out more about Real please visit www.realstaffing.com
Start date
09/2013
Duration
12+ months
(extension possible)
From
Real Staffing
Published at
14.09.2013
Project ID:
598409
Contract type
Freelance
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