US-CA-Bay Area: Quality Assurance Specialist
To apply for this position, please visit this Website.
http://sqa.fyicenter.com/jobs/99682435_Quality_Assurance_Specialist.html
To see other op****tunities, 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 re****ts for complete do***entation 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 re****ts.
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
Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com


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