QA Compliance Inspector – cGMP Manufacturing

Mogi I/O : OTT/Podcast/Short Video Apps for you; City of Poughkeepsie (NY); On-site; USD 43,000 - 62,000; Full time

Job summary

A leading pharmaceutical company is seeking a QA Compliance Inspector to oversee product quality through all stages of manufacturing. This role involves ensuring compliance with cGMP and FDA regulations, especially for Dry Powder Inhaler products. The QA Inspector will conduct quality checks, support investigations, and maintain documentation accuracy. Candidates should have a Bachelor’s degree in Science and 3-5 years of experience in the pharmaceutical industry, with a strong background in quality assurance and familiarity with SAP systems.

Qualifications

• Minimum of 3-5 years of pharmaceutical industry experience.
• Experience with DPI, MDI, or injectable products preferred.

Responsibilities

• Ensure proper cleaning and readiness of manufacturing equipment.
• Perform SAP transactions and support investigations.
• Conduct daily quality rounds for GMP compliance.
• Review batch records and documentation.

Skills

Strong knowledge of cGMP and FDA regulations

IPQA activities oversight

Familiarity with SAP ERP systems

Attention to detail

Self-motivated with multiple priorities

Proficiency in Microsoft Word, Excel, PowerPoint

Education

Bachelor's degree in Science

Tools

SAP

Job description

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

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 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

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