US-CA-San Diego: Sr. Quality Analyst

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 19-Feb-2008

Sr. Quality Analyst

BS with minimum 6-10 years validation experience with IT applications and Laboratory equipment in the pharmaceutical, medical, or biotech industry. Experience with enterprise computer systems and network infrastructure desired. Strong organization skills, written/oral communication, negotiation and interpersonal skills. Necessary characteristics include: being a self-starter, goal-oriented, attention to detail, team-oriented, ability to work independently and proactively, and ability to multi-task. This job may require up to 10-20 percent travel.

RESPONSIBILITIES:

Position reports to Manager or above taking primary responsibility for intermediate to advanced broad-based functional team activities. Will be responsible for providing compliance oversight and guidance for laboratory equipment and computer system selection and validation efforts by reviewing and approving internal validation deliverables. Support the risk management activities for the Software and Quality Systems. Reviews and/or approves validation documentation for internal and contractor process and software validation activities, equipment/software change control documentation, and related standard operating procedures and policies. Manage risk management activities for the Software Quality Systems. Participates in the project teams to ensure the validation activities are in compliance. Improves the productivity and efficiency of the various quality system processes by applying the various quality engineering problem-solving techniques. Supports change control and assists technical and administrative workers engaged in quality systems activities. Develops new approaches to solve problems identified during quality activities. Maintains a working knowledge of regulatory and industry quality assurance codes and standards. Communicates significant issues or developments identified during quality system and device development activities and provides recommended process improvements to management. Formulates and maintains quality engineering objectives complementary to corporate policies and goals. Collaborates with engineering staff, end users, and testers throughout the product life cycle to thoroughly understand applications.

For more information, please write to us.

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