Quality Assurance Specialist II
1 week ago
Job Summary:
Amneal Pharmaceuticals is seeking a highly skilled Quality Assurance Specialist II to oversee and ensure the quality of incoming raw materials, packaging components, and returned goods. The ideal candidate will have a strong foundation in math and exceptional attention to detail, with the ability to maintain quality compliance throughout each packaging run.
Key Responsibilities:
- Perform thorough inspections, sampling, and testing on incoming raw materials, packaging components, and returned goods, following established procedures and protocols.
- Prepare samples for chemical and microbiological analysis and deliver to the Quality Control laboratory.
- Inspect packaging components using measuring devices to verify conformance to specifications, ensuring accuracy and precision.
- Maintain detailed records of sampling, inspections, and testing activities, including documentation and reporting.
- Assign and verify expiry dates for raw materials, ensuring compliance with regulatory requirements.
- Conduct in-process testing per batch record instructions, ensuring adherence to established procedures.
- Prepare product samples for Quality Control laboratory and Quality Assurance retention.
- Maintain standard weights for verification upon receipt of components, ensuring accuracy and precision.
- Inspect labeling components and release labels according to packaging orders, ensuring compliance with regulatory requirements.
- Finalize product inspection reports and perform line clearance, ensuring a smooth production process.
- Monitor facility and product environmental conditions, ensuring a safe and healthy work environment.
- Review engineering records and online batch records for completeness, ensuring accuracy and precision.
- Verify equipment functionality during batch runs, ensuring optimal performance.
- Maintain retention sample room and monitor temperature and humidity levels, ensuring compliance with regulatory requirements.
Additional Responsibilities:
- Dispose of rejected materials and returned drug products following Standard Operating Procedures.
- Conduct environmental monitoring as per schedule, ensuring compliance with regulatory requirements.
- Perform relevant testing and prepare reports for customer complaints, ensuring a high level of customer satisfaction.
- Complete any other duties assigned by management, ensuring a high level of productivity and efficiency.
Requirements:
- High School or General Educational Development (GED) diploma - Required
- 2 or more years of experience in Quality Assurance or a related field - Required
Preferred Skills:
- High energy level and strong organizational skills - Advanced
- Demonstrates creativity and initiative - Advanced
- Basic computer proficiency (Word and Excel) - Intermediate
Specialized Knowledge:
- Strong foundation in math and exceptional attention to detail.
- Record observations to enhance processes.
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