
Quality Assurance Inspector
1w1 week agoAmneal Pharmaceuticals
Brookhaven, US · Full-time · $38,000 – $42,000
About this role
The QA Inspector monitors and ensures all incoming raw materials, packaging components and returned goods are sampled, inspected and tested for compliance with established specifications. Monitors all phases of drug manufacturing to ensure compliance. Receives, inspects, releases and controls labels and outserts for quality before, during and after packaging runs.
Performs inspection, sampling and testing on incoming materials following detailed written procedures. Prepares samples for chemical and microbiological analysis and delivers them to the QC lab. Uses measuring devices such as scales, micrometers and height gauges to verify conformance.
Conducts room, equipment and packaging line checks prior to manufacturing stages. Performs in-process testing per batch records and prepares product samples for QC lab retains. Ensures warehouse compliance with isolation of quarantine, released, in-process, finished and rejected areas.
Handles labeling component receipt, visual exams, quarantine and release while maintaining logs. Monitors facility and product environmental conditions and isolates rejected materials. Operates and calibrates equipment like hardness testers and friabilators per schedules.
Maintains detailed records of activities and observations for process improvements. Works in contained manufacturing areas following all precautions. Performs visual inspections for annual product reviews and other duties as assigned.
Requirements
- High School Diploma or GED required
- 1 year or more in QA or related field
- Good basic math knowledge
- Excellent attention to details
- Records observations for improving processes
- Successful completion of OSHA-compliant Respirator Fit Test
- Familiarity with measuring devices such as scales, micrometers and height gauges
- Knowledge of GMP raw materials through vendor COA and in-house COA
Responsibilities
- Perform inspection, sampling and testing on incoming raw materials, packaging components and returned goods following detailed written procedures
- Prepare samples for chemical and microbiological analysis and deliver to QC lab
- Conduct room, equipment and packaging line checks prior to manufacturing stages
- Perform in-process testing per batch records and prepare product samples for QC retains
- Handle labeling component receipt, visual examination, quarantine, release and maintain logs
- Ensure warehouse compliance with isolation of quarantine, released, in-process and rejected areas
- Monitor facility and product environmental operating conditions
- Operate, maintain and calibrate equipment such as hardness testers, friabilators and weighing scales
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