Quality Assurance Inspector - 2nd Shift
Amneal Pharmaceuticals
4 hours ago
On-site
Brookhaven, NY
Operations
Essential Functions:
- Perform inspection, sampling, and testing (where applicable) of incoming raw materials, packaging components, and returned goods per written procedures; prepare samples for chemical/microbiological analysis (if required) and deliver to QC lab; inspect packaging components using measuring devices (scales, micrometers, height gauges) and maintain detailed records.
- Assign/verify expiry and retest dates using vendor and in-house COAs; collect packaged product samples for annual stability.
- Conduct room, equipment, and packaging line checks (where applicable) prior to manufacturing stages; perform in-process testing per batch record instructions; prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains; maintain standard weights for balance verification.
- Manage labeling components/outserts: receipt, visual examination, counting, preliminary inspection, sampling; prepare inspection reports; quarantine/release labels; maintain incoming component logs/inventory cards; issue labels/outserts per packaging order; monitor/audit label room; complete final labeled product inspection report and final line clearance (labeling/packaging reconciliation).
- Ensure warehouse area compliance (quarantine, released, in-process, finished/packaged product, returned goods, rejected); isolate rejected material and ensure batch-record accountability.
- Monitor facility and product environmental operating conditions.
Additional Responsibilities:
- Operate, maintain, and calibrate testing equipment (hardness tester, friabilator, weight variation system, scales/balances, label counting machine, Kirby Lester tablet counters) and keep calibration records.
- Collect samples to reassay bulk finished product before expiration; work in contained manufacturing areas following precautions.
- Perform visual inspections and prepare APR reports; other duties as assigned.
Qualifications:
- Education: High School or GED (Required)
- Experience: 1+ year in QA or related field (Required)
- Specialized Knowledge/Skills: basic math skills, strong attention to detail, ability to record observations to improve processes.
Required Additional Requirement:
- Successful completion of an OSHA-compliant Respirator Fit Test.
Compensation/Benefits (if part of job description):
- Hourly base salary: $19.50–$21.00 per hour.
- Includes a comprehensive benefits program and 401(k) matching contribution (details provided in posting).
- Perform inspection, sampling, and testing (where applicable) of incoming raw materials, packaging components, and returned goods per written procedures; prepare samples for chemical/microbiological analysis (if required) and deliver to QC lab; inspect packaging components using measuring devices (scales, micrometers, height gauges) and maintain detailed records.
- Assign/verify expiry and retest dates using vendor and in-house COAs; collect packaged product samples for annual stability.
- Conduct room, equipment, and packaging line checks (where applicable) prior to manufacturing stages; perform in-process testing per batch record instructions; prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains; maintain standard weights for balance verification.
- Manage labeling components/outserts: receipt, visual examination, counting, preliminary inspection, sampling; prepare inspection reports; quarantine/release labels; maintain incoming component logs/inventory cards; issue labels/outserts per packaging order; monitor/audit label room; complete final labeled product inspection report and final line clearance (labeling/packaging reconciliation).
- Ensure warehouse area compliance (quarantine, released, in-process, finished/packaged product, returned goods, rejected); isolate rejected material and ensure batch-record accountability.
- Monitor facility and product environmental operating conditions.
Additional Responsibilities:
- Operate, maintain, and calibrate testing equipment (hardness tester, friabilator, weight variation system, scales/balances, label counting machine, Kirby Lester tablet counters) and keep calibration records.
- Collect samples to reassay bulk finished product before expiration; work in contained manufacturing areas following precautions.
- Perform visual inspections and prepare APR reports; other duties as assigned.
Qualifications:
- Education: High School or GED (Required)
- Experience: 1+ year in QA or related field (Required)
- Specialized Knowledge/Skills: basic math skills, strong attention to detail, ability to record observations to improve processes.
Required Additional Requirement:
- Successful completion of an OSHA-compliant Respirator Fit Test.
Compensation/Benefits (if part of job description):
- Hourly base salary: $19.50–$21.00 per hour.
- Includes a comprehensive benefits program and 401(k) matching contribution (details provided in posting).