Amneal Pharmaceuticals · 2 days ago
Quality Assurance Inspector
Amneal Pharmaceuticals is a company that specializes in drug manufacturing, and they are seeking a Quality Assurance Inspector to ensure compliance with established specifications for raw materials and packaging components. The role involves monitoring all phases of drug manufacturing, conducting inspections, and maintaining detailed records of quality compliance activities.
ManufacturingMedicalPharmaceutical
Responsibilities
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
Operate, maintain and calibrate Hardness tester, Friabilitor, Weight Variation system, weighing scales and balances, label counting machine, and Kirby Lester tablet counters according to established schedules and maintain detailed calibration records
Collection of 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
Qualification
Required
High School or GED - Required
1 year or more in QA or related field
High energy level and organizational skills. - Advanced
A certain degree of creativity and latitude is required. - Intermediate
Basic computer skills (Word and Excel) - Intermediate
Good basic math knowledge and excellent attention to details
Records observations for improving processes
Benefits
Above-market, diverse and robust health and insurance benefits
Significant 401(k) matching contribution
Programs that helps you enjoy your career alongside life’s many other commitments and opportunities
Company
Amneal Pharmaceuticals
Amneal Pharmaceuticals manufactures, markets and/or distributes more than 88 drugs in the United States.
H1B Sponsorship
Amneal Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (25)
2024 (32)
2023 (33)
2022 (33)
2021 (42)
2020 (34)
Funding
Current Stage
Public CompanyTotal Funding
$3.2B2023-11-16Post Ipo Debt· $2.35B
2018-05-07IPO
2017-10-01Post Ipo Equity· $854M
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