Amneal Pharmaceuticals
Quality Assurance Inspector - 2nd Shift
Amneal Pharmaceuticals, Piscataway, New Jersey, United States
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Overview
The QA Inspector monitors and ensures 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. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run. Essential Functions
Perform inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Prepare samples for chemical and microbiological analysis (where required) and deliver them to the QC lab. Inspect and test packaging components utilizing measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintain detailed records of sampling, inspections and testing activities. Assign and verify expiry date and retest date for GMP raw materials through vendor COA and in-house COA. Collect 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. Maintain standard weights required to perform daily verification of balances. Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Prepare labeling components/outserts inspection reports; quarantine and release labels and maintain 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 and final line clearance, including labeling and packaging reconciliation paperwork. Ensure compliance of the Warehouse area across Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Additional Responsibilities
Operate, maintain and calibrate hardness tester, friabilator, weight variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters; maintain detailed calibration records. Collect samples to reassay bulk finished product before expiration. Work in a contained manufacturing area/facility following all precautions and procedures. Visual inspection and preparation of report of all products for APR. Other duties as assigned by management. Education
High School or GED - Required Experience
1 year of experience in Quality Assurance or related field Skills
Strong organizational skills. - Advanced Creativity and problem solving skills. - Intermediate Basic computer skills (Word and Excel) - Intermediate Specialized Knowledge
Basic math knowledge Attention to details Records observations for improving processes Understanding of Good Manufacturing Practices (cGMP) Proficient in following Standard Operating Procedures (SOPs) Compensation and Benefits
The hourly rate for this position ranges from $19.00 to $23.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what 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, experience, 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 help you enjoy your career alongside life’s many other commitments and opportunities. Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
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The QA Inspector monitors and ensures 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. The QA Inspector must monitor and ensure all phases of drug manufacturing are in compliance with established specifications; receive, inspect, release and control of labels and outserts, to ensure quality compliance before, during and after each packaging run. Essential Functions
Perform inspection, sampling and testing where applicable on all incoming raw materials, packaging components and returned goods following detailed written procedures. Prepare samples for chemical and microbiological analysis (where required) and deliver them to the QC lab. Inspect and test packaging components utilizing measuring devices such as scales, micrometers and height gauges to determine conformance to specifications. Maintain detailed records of sampling, inspections and testing activities. Assign and verify expiry date and retest date for GMP raw materials through vendor COA and in-house COA. Collect 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. Maintain standard weights required to perform daily verification of balances. Labeling component receipt, visual examination, counting, preliminary inspection and sampling. Prepare labeling components/outserts inspection reports; quarantine and release labels and maintain 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 and final line clearance, including labeling and packaging reconciliation paperwork. Ensure compliance of the Warehouse area across Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas. Ensure proper isolation of rejected material generated during batch process and accountability in the batch record. Monitor facility and product environmental operating conditions. Additional Responsibilities
Operate, maintain and calibrate hardness tester, friabilator, weight variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters; maintain detailed calibration records. Collect samples to reassay bulk finished product before expiration. Work in a contained manufacturing area/facility following all precautions and procedures. Visual inspection and preparation of report of all products for APR. Other duties as assigned by management. Education
High School or GED - Required Experience
1 year of experience in Quality Assurance or related field Skills
Strong organizational skills. - Advanced Creativity and problem solving skills. - Intermediate Basic computer skills (Word and Excel) - Intermediate Specialized Knowledge
Basic math knowledge Attention to details Records observations for improving processes Understanding of Good Manufacturing Practices (cGMP) Proficient in following Standard Operating Procedures (SOPs) Compensation and Benefits
The hourly rate for this position ranges from $19.00 to $23.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what 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, experience, 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 help you enjoy your career alongside life’s many other commitments and opportunities. Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
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