Quality Assurance inspector (DPI, MDI, or Injectables)

Job Title: QA Inspector I - (DPI, MDI, or Injectables)

Location: Hauppauge, NY
Shift: First Shift (7:00 AM - 3:30 PM), 9/80 Schedule
Employment Type: Full-Time
Compensation: $16.64 - $22.88 per hour
Relocation: Up to $6,000 offered

Position Overview:

We are seeking a QA Inspector I - (DPI, MDI, or Injectables) to ensure product quality and compliance throughout all phases of manufacturing and packaging. The ideal candidate will possess hands-on experience in pharmaceutical production environments, with a strong understanding of cGMP, SOPs, and quality standards.

Key Responsibilities:

• Verify raw materials during the dispensing process.
• Dispense printed packaging materials to packaging lines.
• Perform in-process checks during manufacturing and packaging per batch record instructions.
• Collect in-process blend, finished product, and validation samples per protocols (including blend uniformity sampling).
• Clean and maintain sampling tools and equipment.
• Conduct IPQA tests (LOD, Bulk/Tapped Density, Leak Test, Weight Variation).
• Ensure equipment and area cleaning, and provide line clearance.
• Perform material postings and transactions in SAP (ERP system).
• Participate in investigations of deviations, OOS, OOT, and non-conformances.
• Review batch records, equipment logs, and calibration/PMP reports.
• Ensure proper isolation and accountability of rejected materials.
• Conduct daily quality rounds to ensure GMP compliance.
• Escalate discrepancies and daily shop floor updates to QA Management.
• Support other quality and compliance activities as assigned.

Qualifications:

• Education: Minimum Bachelor's degree in Science or related field.
• Experience: 1-2 years in pharmaceutical manufacturing (DPI, MDI, or Injectables preferred).
• Skills & Competencies:
  • Knowledge of Good Manufacturing Practices (GMP) and 21 CFR Part 820.
  • Strong communication (verbal/written) and interpersonal skills.
  • Ability to work independently in a fast-paced manufacturing setting.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint).
  • Experience with SAP or similar ERP systems preferred.

Additional Information:

• Work Authorization: US Citizen / Green Card Holder / STEM OPT / H1B Transfer (must have 3 years remaining on visa).
• STEM OPT: Must remain on company payroll for 2 years.
• Relocation: Up to $6,000 available.
• Industry Requirement: Pharmaceutical experience is mandatory (Biopharma experience not applicable).

Benefits:

Comprehensive benefits package including:
401(k) with company match, health insurance (medical, dental, vision), HSA & FSA options, paid vacation/sick/flex time, paid holidays, parental and family leave, disability coverage, and employee discounts.

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