Quality Assurance Specialist II

1 week ago


Piscataway, New Jersey, United States Amneal Pharmaceuticals Full time

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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