Quality Assurance Inspector II - 2nd Shift

Regulatory Toolkit; Town of Brookhaven (NY); On-site; USD 29,000 - 37,000; Full time

Job summary

Amneal Pharmaceuticals in the United States is seeking a QA Inspector I to monitor and inspect incoming raw materials, packaging components, and returned goods, ensuring compliance with established specifications. The role covers labeling control, packaging checks, and release activities throughout the production cycle.

The position requires at least 2 years of QA experience, a High School diploma or GED, and OSHA respirator fit test completion.

Qualifications

• High School diploma or GED required.
• Minimum 2 years QA experience in related field.
• Knowledge of GMP/QA documentation practices.

Responsibilities

• Perform inspection and sampling of incoming materials, packaging components and returned goods.
• Conduct chemical/microbiological testing where applicable and report results to QC.
• Maintain and verify records of sampling, inspections and test results.
• Assign and verify expiry/retest dates for GMP raw materials.
• Prepare labeling components/outserts inspection reports and logs.
• Support final product release and batch record reconciliation as needed.

Skills

Attention to detail

Math skills

Education

High School or GED

Job description

Description:

To monitor and ensure all incoming raw materials, packaging components and returned goods are sampled, inspected and tested (where applicable) for the purpose of determining compliance with established specifications. To monitor and ensure all phases of drug manufacturing are in compliance with established specifications. To receive, inspect, release and control of labels and outserts. To ensure quality compliance before, during and after each packaging run.

Essential Functions:

• All Functions of QA Inspector I, Perform Inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab. Inspection and test of packaging components utilizing various measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintaining detailed records of sampling, inspections and testing activities. Assigning and verification of expiry date and retest date for all the GMP raw materials through vendor COA and in-house COA. Collection of packaged product samples for annual stability. Perform room, equipment, and packaging line checks (where applicable) prior to each stage of manufacturing following detailed written procedures. Conduct in process testing per manufacturing and packaging batch record instructions. Prepare controlled / uncontrolled / packaged finished product samples for QC lab and QA retains, following detailed documentation procedures. Maintenance of standard weights required to perform daily verification of balances. Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Preparation of labeling components/ outserts inspection reports; quarantine and release labels and maintaining incoming components log and corresponding inventory cards. Issuance of labeling components/ outserts according to packaging order and regular monitoring and auditing of label room. Fill out the QA final labeled product inspection report, final line clearance which includes labeling and packaging reconciliation paperwork. Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Plus the following:
• Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions)
• Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step
• Verification of functionality of all the equipment and associated controls during the batch run
• Maintenance of retention sample room and monitoring of temperature and humidity, replacement fo chart records as per schedule, review of log and disposition of samples.

Additional Responsibilities:

• Disposition of rejected material and returned drug products as per SOP
• Performs environmental monitoring in accordance with established schedule (where applicable)
• Perform applicable testing and prepare report for customer complaints
• Other duties that management may from time to time assign.

Education:

• High School or GED - Required

Experience:

• 2 years or more in 2 or more years experience in QA or related field

Specialized Knowledge:

• Good basic math knowledge and excellent attention to details.
• Records observations for improving processes.

Additional Requirement:This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The hourly base salary for this position ranges from $21.00 to $27.00 per hour. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.

Amneal Pharmaceuticals will not sponsor work authorization for this position now or in the future.