Please note that this is a 1 year contract position.
QUALITY ANALYST - SCIENTIFIC - Generally requires (0-2) years related experience. • Recent college graduate with Life Science/Chemistry/Engineering Degree in Medical Technology or equivalent scientific field is preferred. • Understanding and application of scientific principles and methodologies with regard to medical technology, and life science. • Basic knowledge of FDA, QSR, ISO and GMP requirements for pharmaceuticals and medical devices (or will train). • Additional skills required for this position include the following: the ability to schedule work load to meet department and team goals with minimum supervision, good organizational and time management skills to meet multiple and changing priorities, good written and verbal communication skills, the ability to interact with various department personnel. • Strict attention to detail and the ability to focus attention and work in a fast paced environment are key to success in this position.
QUALITY ANALYST - SCIENTIFIC: Reviews executed medical device history records (batch records, testing records, forms, temperature charts, autoclave charts) to: o Verify the accuracy of the record. o Ensure the records are executed as required. o Ensure the records are compliant to Specifications/Requirements, Quality System Regulations and GMPs. o Ensure compliance with established processes and procedures. • Provides final approval of executed device history records. • Follows up with Operations or Laboratory personnel to correct errors in device history records. • Generates Nonconformance records in the electronic Nonconformance Management system when Nonconformance’s are identified during a device history record review. • Prepares and verifies accuracy of Certificates of Analysis and Certificates of Manufacturing. • Uploads approved CoAs and Antigrams to applicable electronic systems. • Supports investigations for customer complaints by performing batch review of impacted area. • Files completed Device History records and Device History files. • Assists in the archiving of Device History Files and other quality records. Recent college graduate with Life Science/Chemistry/Engineering Degree in Medical Technology or equivalent scientific field is preferred.
Applicants must provide their phone number. Please reference job number 3037.