Amneal Pharmaceuticals
Quality Assurance Inspector II - 2nd Shift
Amneal Pharmaceuticals, Piscataway, New Jersey, United States
Quality Assurance Inspector II - 2nd Shift
Join to apply for the
Quality Assurance Inspector II - 2nd Shift
role at
Amneal Pharmaceuticals Quality Assurance Inspector II - 2nd Shift
Join to apply for the
Quality Assurance Inspector II - 2nd Shift
role at
Amneal Pharmaceuticals 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.
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 perfomr 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 reconcilaiton / 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
Skills:
High energy level and organizational skills. - Advanced A certain degree of creativity and latitude - Advanced Basic computer skills ( Word and Excel) - Intermediate
Specialized Knowledge:
Good basic math knowledge and excellent attention to details. Records observations for improving processes.
The hourly rate for this position ranges from $19.00 to $27.00 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.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Amneal Pharmaceuticals by 2x Sign in to set job alerts for “Quality Assurance Inspector” roles.
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Join to apply for the
Quality Assurance Inspector II - 2nd Shift
role at
Amneal Pharmaceuticals Quality Assurance Inspector II - 2nd Shift
Join to apply for the
Quality Assurance Inspector II - 2nd Shift
role at
Amneal Pharmaceuticals 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.
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 perfomr 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 reconcilaiton / 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
Skills:
High energy level and organizational skills. - Advanced A certain degree of creativity and latitude - Advanced Basic computer skills ( Word and Excel) - Intermediate
Specialized Knowledge:
Good basic math knowledge and excellent attention to details. Records observations for improving processes.
The hourly rate for this position ranges from $19.00 to $27.00 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.
Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Amneal Pharmaceuticals by 2x Sign in to set job alerts for “Quality Assurance Inspector” roles.
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr