Mogi I/O : OTT/Podcast/Short Video Apps for you
Senior QA Inspector – Dry Powder Inhalation
Mogi I/O : OTT/Podcast/Short Video Apps for you, Edison, New Jersey, us, 08818
Senior QA Inspector – Dry Powder Inhalation
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
Job Overview 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, OVerify 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 Escalate 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
Required Qualifications
Bachelor’s degree in Science (minimum requirement)
Minimum 3–5 years of pharmaceutical industry experience
Experience with DPI, MDI, or Injectable products preferred
Skills & Competencies
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 PowerPoint
Strong organizational and problem-solving skills
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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
Job Overview 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, OVerify 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 Escalate 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
Required Qualifications
Bachelor’s degree in Science (minimum requirement)
Minimum 3–5 years of pharmaceutical industry experience
Experience with DPI, MDI, or Injectable products preferred
Skills & Competencies
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 PowerPoint
Strong organizational and problem-solving skills
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