US-CA-Bay Area: Quality Assurance Specialist

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 17-Jun-2008

Quality Assurance Specialist

The job involves close interaction with the staff on technical issues with the products and on the mechanics of the Quality System, and interfaces with the entire organization.

Essential Functions:

* Reviews and releases manufacturing batch records, deviations and nonconformances. * Tracks Corrective and Preventive Actions, performs root cause analysis and troubleshooting investigations. * Reviews nonconformance reports for complete documentation of issue and root cause. * Assists in revision and writing of Standard Operating Procedures. * Develops and conducts new employee training. * Coordinates and performs internal quality audits. * Coordinates and performs supplier audits and supplier qualifications. * Reviews validation reports.

Preferred Education/Experience:

* Bachelors Degree or equivalent experience * Minimum of 5 years of experience in biotechnology or medical devices * Previous experience in quality assurance functions

Preferred Technical Skills:

* Knowledgeable in FDA QSR and ISO 13485. * Proficient in computer software application programs such as Word, Excel, PowerPoint, and database.

Preferred Interpersonal/Other Skills:

* Self-starter, self-motivated, adaptable, able to work with minimal direction in a high pressure environment. * Strong organizational and collaborative skills, good attention to detail, time management skills and personal initiative. * Strong ethics

For more information, please write to us.

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