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Job Id: 257597

3rd shift shift; 10:00 PM to 6:30 AM Sunday to Thursday plus weekends if needed.
SUMMARY OF POSITION: This position is primarily responsible for performing Quality Control testing products at various stages of Production. This includes both routine (SOP) and special assignments as well as documentation of findings/results for attachment to Device History Records. Additionally this individual will lend support as necessary to the daily QC Chemistry core functions – Stability Studies Raw Material Testing Proficiency Testing and Customer Complaints.

ESSENTIAL FUNCTIONS: Ø Performs and documents QC Sofia Testing of WIP Production Lots and special evaluation assignments Ø Supports daily QC Chemistry core functions as needed Ø Performs and documents 1st article functional Sofia Final Kit QC Testing Ø Support new Sofia product development/improvement projects Ø General housekeeping and laboratory organization Ø Carries out duties in compliance with established business policies Ø Works and communicates effectively and professionally with others Ø Capable of working and communicating with other departments regarding testing activities Ø Operate laboratory equipment safely as trained and directed in accordance with established practices Ø Train new Quality Control Technicians

Education/Experience Ø High School education or equivalent. Ø 0-2 years’ in Quality Control or manufacturing laboratory environment. Ø Experience in a medical device high-volume manufacturing environment strongly desired. Knowledge/Skills Ø Ability to read interpret and follow detailed procedures instructions and drawings Ø Solid understanding of QSRs/ISO Ø General chemistry and laboratory skills GLP/GMP experience Ø Demonstrated team-oriented interaction skills/professional behavior Ø Strong written and verbal communication skills Ø Proficient word processing data entry and spreadsheet navigation skills Ø Must know basic quality terms definitions and concepts Ø Must understand traceability (product material and calibration

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