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QC General Inspector

Company: Threshold Enterprises
Location: Scotts Valley
Posted on: November 24, 2020

Job Description:

Summary of Job Duties: The Quality Control General Inspector is responsible for various Quality Control Procedures and related inspections to FDA, GMP, and Threshold established guidelines and specifications. Including but not limited to Label inspections, retention sample intake and discard, as well as assisting with raw material and bulk sampling, inspections, or material handling (power equipment) as part of the quality team. This position also participates in multi-departmental investigatory and review processes, and works closely with all Quality group teams, Production Control, Production, Printshop, Graphics, Marketing and Research & Development to ensure cGMP compliance of label content and of production processes. Specific Job Duties: 1. Responsible for working cooperatively and proactively in a professional and effective manner with Quality team members, Production control, Production, Printshop, Graphics, Marketing and Research & Development to ensure cGMP compliance of label content and of production processes. 2. Perform Quality Control inspections of Labels generated by in-house print shop or international clientele according to Threshold s (DSHEA and FDA) established specifications. 3. Complete label routing and inspection documentation and in station quality checks accurately, completely and with great attention to the necessary DSHEA, FDA and GDP guidelines. 4. Operate the label rewind table to inspect integrity of label run (single label revs or product codes even after splicing) and review labels for printing and other acceptable quality limit (AQL) defects. 5. Maintain physical storage and electronic database of Bindery and QC label inspection documentation and samples (including discard after retention period is over). 6. Assist in warehouse by operating powered equipment, including forklift, walkie-stacker, reach truck, and electric pallet jack to remove pallets from shelves. 7. Assist other Technical Analysts or Quality team members in stickering raw material and finished product lots as released or rejected in the warehouses. Including NAV operations as appropriate. 8. All other duties assigned by management, which may include document routing (purchase requisitions, lab testing PO s, deviations etc.), test sample shipment and delivery tasks, and performing various administrative (area equipment calibration oversight), and investigative tasks. 9. Perform all other duties assigned by Threshold management, which may include performing various administrative (area equipment calibration oversight) and investigative tasks. Qualifications Minimum Qualifications Required: 1. Excellent written and verbal skills. 2. High school diploma or GED. 3. Ability to lift 30+ pounds and sit for extended periods of time. 4. Ability to work competently with computer technology at a medium skill level - Excel, Word, and email programs. 5. Demonstrate strong detail-orientation and ability to work in a fast-paced team environment. 6. Self-starter with the ability to learn and grow with changing role needs, able to work with little or no supervision and maintain a strong work ethic. Skills and/or Training Desired: 1. Above average skills in Excel, Word, and Outlook. Powerpoint, excel data table set up and maintenance, Access Databases and ERP program knowledge a plus. 2. Quality Control, QA, medical device, or other inspection experience. 3. Experience with powered equipment (forklift, walkie-stacker, reach truck, and/or electric pallet jack). 4. Experience with inspection equipment (Lederle table or other basic inspection equipment, compressed air systems).

Keywords: Threshold Enterprises, San Francisco , QC General Inspector, Other , Scotts Valley, California

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