FDA Adverse Event/ Quality Analyst

Global adverse event reporting, FDA Quality Systems Regulations, CMDE, ISO13485, Microsoft Office, CMDR, Quality Assurance, Quality Systems, GMP Operations.
Contract W2, 12 Months
Depends on Experience
Travel not required

Job Description

Please note that this is a 1 year contract position. 

Qualifications:
 Generally requires (2-4) years related experience • Broad-based knowledge and skills in Quality Assurance, Quality Systems, GMP Operations. • Good working knowledge of related functions such as operations and laboratory operations. • Basic knowledge of FDA Quality Systems Regulations, CMDR and ISO13485 standards. • Demonstrated knowledge of business impact of compliance issues. • Ability to use Microsoft Office products effectivly (Outlook, Word, Excel). • Highly organized. • Detailed knowledge of FDA Quality Systems Regulations, CMDE and ISO13485. • Knowledge of global adverse event reporting requirements is preferred. • Education: Minimum of High School Diploma

Responsibilities:
• Coordinate the receipt and handling of all records in the Product Quality department which includes: • Granting access of personnel into the controlled Product Quality area. • Logging records received into a database. • Stamping records or ensuring they are stamped with the date/time. • Verifying records received to the applicable log form. • Creating the physical Device History files that are used to file reviewed/approved Device History records. • Filing records appropriately into the correct Device History files or other filing location. • Retrieval of records for FDA or other audits. • Archiving records as needed. • Retrieves and verifies accuracy of printed Device History records. • Stages printed Device History records for retrieval by its applicable department. • Prepares and verifies accuracy of Certificates of Analysis and Certificates of Manufacturing. • Uploads approved CoAs and Antigrams to applicable electronic systems. Reviews charts and other documents relevant to the lot file.

Applicants must provide their phone number.Reference job number A283. 

Posted By

San Francisco, CA, 94159

Contact
Dice Id : NETSO
Position Id : A283
Originally Posted : 1 month ago
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