Amneal Pharmaceuticals · 1 week ago
Quality Assurance Inspector II - 3rd Shift
Amneal Pharmaceuticals is a company focused on pharmaceutical manufacturing, and they are seeking a Quality Assurance Inspector II for the 3rd shift. The role involves monitoring and ensuring compliance of raw materials and packaging components, conducting inspections, and maintaining quality standards throughout the manufacturing process.
ManufacturingMedicalPharmaceutical
Responsibilities
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 using various 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 dates and retest dates for all 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
Handle labeling component receipt, visual examination, counting, preliminary inspection, and sampling
Prepare labeling components/outserts inspection reports; quarantine and release labels; maintain incoming components log and corresponding inventory cards
Issue labeling components/outserts according to packaging order and regularly monitor and audit the label room
Complete QA final labeled product inspection report and final line clearance, including labeling and packaging reconciliation paperwork
Ensure compliance of warehouse areas in terms of 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
Review engineering records (temperature and humidity data, calibration and PM records, pest control records, and contractor-related functions)
Review online batch records for completeness of signatures, entries, and reconciliation/yields prior to initiation of the next processing step
Verify functionality of all equipment and associated controls during the batch run
Maintain retention sample room and monitor temperature and humidity; replace chart records as per schedule; review logs 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 assign
Qualification
Required
High School or GED - Required
Must have 2 years or more 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
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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