Raw Material Inspector
747 Grayson Street Berkeley, CA 94710 US
The QC Raw Material Chemistry group is responsible for inspection and sampling of raw materials chemicals and hardgoods to ensure quality.
The candidate analyst will perform inspections of incoming raw materials by review of Certificates, visual inspection, and sampling of materials and chemicals.
POSITION DUTIES & RESPONSIBILITIES:
- Inspect Raw Materials using functional testing devices, micrometers, calipers or gauges, optical comparators, profile projectors and/or other analytical devices.
- Determine sample size and accept/reject criteria by operating an Acceptable Quality Level (AQL) Slide Rule.
- Identify and classify defects by type. Using statistical tools and arithmetic calculations, limit samples and written procedures to base the decision of acceptance or rejection of raw materials.
- Evaluate inspection results vs specification.
- Record/Enter inspection results into SAP
- Using aseptic technique, sample chemicals and other materials, maintaining sterility/low Bioburden-endotoxin state of samples and parent container(s), completing necessary records, and submit for laboratory analysis as required.
- Maintain work area and equipment to cGMP standards.
- Maintain specifications and inspection and retain sample files and logs.
- Minimum Education: Must have at least 1 college-level mathematics and statistics course or equivalent ability to be able to use statistical sampling plans such as ANSI/ASQ Z1.4, to navigate an AQL slide rule accurately and to be able to perform calculations such as ratios and percentages. Courses in Microbiology and Chemistry preferred.
- Minimum Experience: Minimum 1+ years of experience in chemical handling and visual inspection.
- Must be able to follow detailed written procedures and maintain neat, accurate and legible written records. Must be able to understand and interpret detailed records and specifications.
- Aseptic technique and attention to detail is essential
- Familiar with cGMP.
- Must be able to visualize labels, print quality and very fine font clarity of print, and must be able to discern very subtle color variations. Must be able to pass annual eye exam for inspectors.
- Must be able to manipulate cases weighing up to 49 lbs., push 300+ lbs. of material on a wheeled cart. Bending, stooping, carrying, standing, kneeling and exposure to temperatures as cold as -30C are required.
- Familiarity with a pharmaceutical, clinical or Quality Control working environment is desirable.
- SAP experience preferred.
Travel Requirements: (if applicable)
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