Amneal Pharmaceuticals · 1 day ago
Quality Assurance Inspector II
50 Horseblock Road, Brookhaven, NY, 11719, US
Full-time
Onsite
Entry, Mid Level
$22/hr - $25/hr
2+ years expAmneal Pharmaceuticals is a company focused on quality assurance in the pharmaceutical industry, and they are seeking a Quality Assurance Inspector II. The role involves monitoring and ensuring compliance of raw materials and packaging components, conducting inspections and tests, and maintaining detailed records of activities related to quality assurance.
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 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
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 of chart records as per schedule, review of log and disposition of samples
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
Qualification
Required
High School or GED - Required
2 or more years experience in QA or related field
High energy level and organizational skills. - Advanced
A certain degree of creativity and latitude - Advanced
Basic computer skills ( Word and Excel) - Intermediate
Good basic math knowledge and excellent attention to details
Records observations for improving processes
This position requires successful completion of an OSHA-compliant Respirator Fit Test
Benefits
Above-market, diverse and robust health and insurance benefits
Significant 401(k) matching contribution
Company
Amneal Pharmaceuticals
Amneal Pharmaceuticals manufactures, markets and/or distributes more than 88 drugs in the United States.
5001-10000 employees
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
Leadership Team
Chirag Patel
President & Co-Chief Executive Officer
Recent News
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