Quality Assurance Associate

Quality Assurance Associate Needed Now in Westlake Village! Pay: $40K - $45K (DOE) Hours: 8:00 am - 5:00 pm Schedule: Monday - Friday Temporary Position- Immediately Needed Job Description: Assume Quality Assurance Department''s responsibility including plant and laboratory Drug GMP compliance. Prepare and issue new and revised SOP papers. File and organize SOPs, Production/Technical documentation, and QC data. Issue and review batch records, maintain filing system, and assist with annual product reviews. Monitor production line as needed. Job Responsibilities: Responsible for issuing, approving, and reviewing packaging batch records and for issuing and approving in-process batch records. Maintain batch record filing system including final batch reconciliations. Write new SOPs or revise existing SOPs for different departments in the facility. Maintain SOP files and SOP audit system including all controlled documents. Makes changes to controlled documents in need of updates or revisions. Evaluate and investigate customer complaints. Maintain complaint files. Monitor shipping and production lines, as needed. Compile data for annual product reviews. File and organize department''s production/technical papers, memos, and correspondences for day-to-day smooth operation and administration of the department. Responsible for preparing International COA''s and reviewing international orders. Maintain Employee Training files and database. Responsible for calibrating thermometers and updating the thermometer calibration database. Perform daily temperature checks, monitor deionized water, and conduct dissolved solids testing. Responsible finished product evaluation reports retained sample examination reports, and for disposing of old products put aside for testing, as well as organizing and sorting out new products for both testing and stability. Annual Product Reviews Responsible for conducting physical appearance examinations. Evaluate all incoming new and existing label prints for production use. Initiate packaging material approvals.

Created: 2021-11-29