QA Compliance Inspector – cGMP Manufacturing
Listed on 2026-01-14
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Quality Assurance - QA/QC
Quality Technician/ Inspector, Quality Engineering, Quality Control / Manager, QA Specialist / Manager -
Manufacturing / Production
Quality Engineering, QA Specialist / Manager
QA Compliance Inspector – cGMP Manufacturing
Location:
Hauppauge, New York, USA
Employment Type:
Full-Time | Permanent
Shift: 2nd
Shift: 3:00 PM – 11:30 PM (Must be flexible to work 1st, 2nd, or 3rd shift based on business needs)
Work Schedule:
Monday–Friday, Tuesday–Saturday, or rotating schedules as required
Experience
Required:
3–15 years (Pharmaceutical manufacturing experience required; DPI preferred)
Compensation: USD 43,000 – 62,000 per year / Hourly Rate: USD 21 – 30/hour
The QA Inspector III (2nd Shift) is responsible for ensuring product quality throughout all stages of pharmaceutical manufacturing and packaging operations. This role ensures compliance with cGMP, FDA regulations, and company quality systems, with a primary focus on Dry Powder Inhaler (DPI) products. The position supports in-process quality assurance activities, documentation review, shop floor compliance, and investigation support within a regulated manufacturing environment.
Key Responsibilities- Ensure proper cleaning, line clearance, and readiness of manufacturing and packaging equipment
- Perform SAP (ERP) transactions, including posting dispensed materials and sample records
- Support investigations related to deviations and verify raw materials during the dispensing process to ensure accuracy and compliance
- Dispense printed packaging materials to packaging operations as per approved procedures
- Perform in-process quality checks during manufacturing and packaging in accordance with batch records
- Collect in-process, finished product, and validation samples per approved protocols
- Perform Blend Uniformity (BU) sampling, including cleaning and maintenance of sampling tools
- Conduct IPQA testing on the manufacturing floor, including loss on drying (LOD), bulk density, tapped density, leak testing, weight variation testing, OS, OOT, and non-conformances
- Review batch records, equipment and area logbooks, calibration records, and PMP documentation
- Ensure proper identification, segregation, and documentation of rejected materials
- Review engineering and environmental records, including temperature and humidity data
- Conduct daily quality rounds on the manufacturing floor to ensure GMP compliance
- Report and elevate shop floor issues and discrepancies to the QA Manager
- Complete all required training assignments and adhere to company policies, safety standards, SOPs, and cGMP requirements
- Perform additional QA support activities as assigned by management
- Bachelor’s degree in Science (minimum requirement)
- Minimum 3–5 years of pharmaceutical industry experience
- Experience with DPI, MDI, or injectable products preferred
- Strong knowledge of cGMP and FDA regulations (21 CFR Part 820)
- Experience with IPQA activities and shop floor quality oversight
- Familiarity with SAP ERP systems
- Ability to read, write, and communicate effectively
- Strong attention to detail and documentation accuracy
- Self-motivated with the ability to manage multiple priorities in a fast-paced environment
- Proficiency in Microsoft Word, Excel, and Power Point
- Strong organizational and problem-solving skills
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