US-CA-San Diego: Staff QA Auditor

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 22-Feb-2008

Staff QA Auditor (software)

BS in Computer Science or equivalent IT experience with 3-5 years of computer system related experience in the pharmaceutical, medical, or biotech industry. Two to three years compliance audit experience with Enterprise systems and network infra structure required. Strong written/oral communication, negotiation and interpersonal skills. Excellent organization skills. Necessary characteristics include: attention to detail, team-oriented, ability to work independently and proactively, and ability to multi-task. Experience with clinical trial support systems such as IVRS, and electronic Case Report Forms is essential. This job will require up to 25 percent travel. ASQ CSQE a plus.

RESPONSIBILITES:

Will be responsible for assessing Computer System compliance functions and company qualification, verification and validation efforts by reviewing internal and contractor processes and software validation activities. Reviews validation documentation for internal and contractor processes, and software validation activities, equipment/software change control documentation, and related standard operating procedures and policies.

Maintains a working knowledge of government and industry quality assurance codes and standards. Communicates significant issues identified during quality assurance audit activities to appropriate management teams.

Generates, revises, and maintains Standard Operating Procedures (SOP) governing this audit program. Generates audit reports summarizing audits conducts, establishes and maintain audit files according to SOP, and tracks open corrective action items utilizing an electronic tracking database.

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com