QA Inspector II
Company: Amneal Pharmaceuticals
Posted on: June 24, 2022
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.
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 perform daily verification of
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
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
Review of engineering records (temperature and humidity data
calibration and PM records, Pest control records and contractor
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 fo chart records as per schedule, review
of log and disposition of samples.
Disposition of rejected material and returned drug products as per
Performs environmental monitoring in accordance with established
schedule (where applicable)
Perform applicable testing and prepare report for customer
Other duties that management may from time to time assign.
High School or GED - Required
2 or more years experience in QA or related field - Required
Skills and Abilities
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.
Keywords: Amneal Pharmaceuticals, Trenton , QA Inspector II, Other , Piscataway, New Jersey
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