Please note that this is a 1 year contract position. Qualifications Generally requires (2-4) years related experience bull Broad-based knowledge and skills in Quality Assurance, Quality Systems, GMP Operations. bull Good working knowledge of related functions such as operations and laboratory operations. bull Basic knowledge of FDA Quality Systems Regulations, CMDR and ISO13485 standards. bull Demonstrated knowledge of business impact of compliance issues. bull Ability to use Microsoft Office products effectively (Outlook, Word, Excel). bull Highly organized. bull Detailed knowledge of FDA Quality Systems Regulations, CMDE and ISO13485. bull Knowledge of global adverse event reporting requirements is preferred. bull Education Minimum of High School Diploma Responsibilities bull Coordinate the receipt and handling of all records in the Product Quality department which includes bull Granting access of personnel into the controlled Product Quality area. bull Logging records received into a database. bull Stamping records or ensuring they are stamped with the datetime. bull Verifying records received to the applicable log form. bull Creating the physical Device History files that are used to file reviewedapproved Device History records. bull Filing records appropriately into the correct Device History files or other filing location. bull Retrieval of records for FDA or other audits. bull Archiving records as needed. bull Retrieves and verifies accuracy of printed Device History records. bull Stages printed Device History records for retrieval by its applicable department. bull Prepares and verifies accuracy of Certificates of Analysis and Certificates of Manufacturing. bull 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 A456.
Posting ID: 581891978Posted: 2020-11-30