Amneal Pharmaceuticals
Position Summary
A Quality Assurance Inspector will monitor and ensure compliance of raw materials, packaging components, returned goods, and drug manufacturing phases with established specifications.
Schedule 1st Shift 7:00 AM – 3:30 PM, Monday to Friday.
Essential Functions
Perform inspection, sampling, and testing of all incoming raw materials, packaging components, and returned goods following detailed written procedures.
Prepare samples for chemical and microbiological analysis and deliver them to the QC laboratory.
Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges to ensure compliance with specifications.
Maintain detailed records of sampling, inspections, and testing activities.
Assign and verify expiry and retest dates for all GMP raw materials using vendor COAs and in‑house COAs.
Collect packaged product samples for annual stability studies.
Conduct room, equipment, and packaging line checks prior to each manufacturing stage following written procedures.
Perform in‑process testing as per batch record instructions.
Prepare controlled, uncontrolled, and packaged finished product samples for the QC lab and QA retains following documentation procedures.
Maintain standard weights for daily balance verification, and perform labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
Prepare labeling components/outserts inspection reports, quarantine and release labels, and maintain component logs and inventory cards.
Issue labeling components/outserts according to packaging orders and conduct regular audits of the label room.
File the QA final labeled product inspection report and complete final line clearance, including labeling and packaging reconciliation paperwork.
Maintain proper isolation of quarantine, released, in‑process, finished product, packaged product, returned goods, and rejected areas.
Ensure proper isolation and accountability of rejected material generated during batch processes.
Monitor facility and product environmental operating conditions.
Review engineering records (temperature and humidity, calibration and preventive maintenance, pest control, and contractor records).
Review online batch records for completeness of signatures, entries, and reconciliations prior to subsequent processing steps.
Verify functionality of all equipment and associated controls during the batch run.
Maintain retention sample room, monitor temperature and humidity, replace chart records as scheduled, and review logs and disposition of samples.
Additional Responsibilities
Disposition of rejected material and returned drug products per SOP.
Perform environmental monitoring as per established schedule.
Perform applicable testing and prepare reports for customer complaints.
Other duties as assigned by management from time to time.
Education
High School or GED – Required.
Experience
2 or more years of QA or related experience.
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 detail.
Records observations to improve processes.
Additional Requirements This position requires successful completion of an OSHA‑compliant respirator fit test.
Compensation Hourly base salary ranges from $22.00 to $25.00 per hour.
Benefits Includes a comprehensive, flexible, and competitive benefits program with health, insurance, and a 401(k) matching contribution, among other employee well‑being programs.
Location Yaphank, NY
Equal Employment Opportunity Statement 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.
#J-18808-Ljbffr
Schedule 1st Shift 7:00 AM – 3:30 PM, Monday to Friday.
Essential Functions
Perform inspection, sampling, and testing of all incoming raw materials, packaging components, and returned goods following detailed written procedures.
Prepare samples for chemical and microbiological analysis and deliver them to the QC laboratory.
Inspect and test packaging components using measuring devices such as scales, micrometers, and height gauges to ensure compliance with specifications.
Maintain detailed records of sampling, inspections, and testing activities.
Assign and verify expiry and retest dates for all GMP raw materials using vendor COAs and in‑house COAs.
Collect packaged product samples for annual stability studies.
Conduct room, equipment, and packaging line checks prior to each manufacturing stage following written procedures.
Perform in‑process testing as per batch record instructions.
Prepare controlled, uncontrolled, and packaged finished product samples for the QC lab and QA retains following documentation procedures.
Maintain standard weights for daily balance verification, and perform labeling component receipt, visual examination, counting, preliminary inspection, and sampling.
Prepare labeling components/outserts inspection reports, quarantine and release labels, and maintain component logs and inventory cards.
Issue labeling components/outserts according to packaging orders and conduct regular audits of the label room.
File the QA final labeled product inspection report and complete final line clearance, including labeling and packaging reconciliation paperwork.
Maintain proper isolation of quarantine, released, in‑process, finished product, packaged product, returned goods, and rejected areas.
Ensure proper isolation and accountability of rejected material generated during batch processes.
Monitor facility and product environmental operating conditions.
Review engineering records (temperature and humidity, calibration and preventive maintenance, pest control, and contractor records).
Review online batch records for completeness of signatures, entries, and reconciliations prior to subsequent processing steps.
Verify functionality of all equipment and associated controls during the batch run.
Maintain retention sample room, monitor temperature and humidity, replace chart records as scheduled, and review logs and disposition of samples.
Additional Responsibilities
Disposition of rejected material and returned drug products per SOP.
Perform environmental monitoring as per established schedule.
Perform applicable testing and prepare reports for customer complaints.
Other duties as assigned by management from time to time.
Education
High School or GED – Required.
Experience
2 or more years of QA or related experience.
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 detail.
Records observations to improve processes.
Additional Requirements This position requires successful completion of an OSHA‑compliant respirator fit test.
Compensation Hourly base salary ranges from $22.00 to $25.00 per hour.
Benefits Includes a comprehensive, flexible, and competitive benefits program with health, insurance, and a 401(k) matching contribution, among other employee well‑being programs.
Location Yaphank, NY
Equal Employment Opportunity Statement 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.
#J-18808-Ljbffr