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QA Specialist (Compliance) with Trackwise Exp Needed ASAP (Mira Mesa)


Date: 2009-11-12, 5:39PM PST
Reply to: job-9jmq6-1463584380@craigslist.org [Errors when replying to ads?]


Dear QA Specialist,

One of San Diego's premiere biotech companies is searching for a QA Specialists to join their team for 5-6+ months. Please submit your resume and references as a word document if you are interested in applying. A representative will contact you within 48 hours if there is an interest.

QA Specialist
Duration: 5-6+ months
Shift: 8am-5pm, Monday-Friday
Pay: $24-28/hr, DOE

Job Description:

-Conducts compliance audits of complex documentation & data.
-Perform ERP transactions
-Leads internal and/or walk around audits.
-Assists in external audits & Regulatory Body audits.
-Reviews Customer Notifications and prepare, approve & submit data packages for external customers.
-Performs compliance activities such as Product Holds, room releases, etc.
-Approves compliance assessments & interfaces with other departments and business partners for complaints, investigations, etc.
-Conducts technical troubleshooting activities & investigation analysis.
-Performs technical support of QA Systems.

Qualifications Required:

BS Degree with at least 3 years experience in the Quality Assurance for the Medical Device Industry or Medical Laboratory experience.
A working knowledge of QC, Manufacturing, Inventory processes and 21CFR.820 and ISO 13485 requirements.
Must be experienced with SAP and TrackWise
Good Communication skills
Attention to Detail
Strong Organization skills
Strong Problem Solving skills
Team Orientation
Working knowledge of Microsoft Word, Excel and related functions including the formulation of graphs.


PostingID: 1463584380