Job Description
Job Title: DPI QA Inspector II
Location: Hauppauge, NY
Employment Type: Full-Time
Shift: General (8:30 AM – 5:00 PM) – Subject to change based on business needs
Experience Required: 3 - 15 YearsJob Summary
We are seeking a detail-oriented and quality-focused DPI QA Inspector II to join our pharmaceutical manufacturing team in Hauppauge, NY. The ideal candidate will have 1-2 years of prior experience in pharmaceutical manufacturing (preferably in DPI, MDI, or Injectables), with a strong understanding of current Good Manufacturing Practices (cGMP) and compliance regulations such as 21 CFR Part 820.Key Responsibilities
Monitor and ensure product quality throughout all stages of manufacturing and packaging.
Perform verification of raw materials during dispensing and dispensing of printed packaging materials.
Conduct in-process checks during batch manufacturing and packaging in accordance with batch records.
Collect in-process blend, finished product, and validation samples, including Blend Uniformity (BU) sampling.
Conduct IPQA testing on the manufacturing floor including:
Loss on Drying (LOD)
Bulk Density
Tapped Density
Leak Test
Weight Variation Test
Oversee and document cleaning and line clearance for manufacturing and packaging equipment/areas.
Post dispensed materials and samples into SAP and perform relevant ERP transactions.
Participate in investigations of Deviations, OOS, OOT, and other non-conformances.
Review batch records, logbooks, calibration and preventive maintenance reports.
Ensure proper segregation and documentation of rejected materials during processing.
Conduct daily quality rounds on the shop floor to ensure compliance with cGMP standards.
Escalate discrepancies or issues to Quality Assurance Management.
Complete assigned training and follow all applicable safety, quality, and company policies.
Perform additional duties as assigned by management.Required Qualifications
High School Diploma or equivalent with strong science exposure.
Minimum of 1-2 years of pharmaceutical industry experience (DPI, MDI, or Injectables required).
Experience with solid, liquid, tablet, and capsule dosage forms preferred.
Strong knowledge of Good Manufacturing Practices (GMP) and 21 CFR Part 820.
Effective communication skills (verbal and written).
Proficiency in basic computer applications (Microsoft Word, Excel, PowerPoint).
Strong attention to detail and organizational skills.
Fundamental math and analytical skills.Physical Requirements
Ability to stand or walk unassisted for 75% or more of an 8-hour shift.
Ability to lift up to 35 lbs. unassisted.
Must wear required personal protective equipment (PPE) such as lab coats, gloves, safety glasses, and respirators as needed.
Must be able to work with or around solvents, powders, and other pharmaceutical materials.Work Authorization Requirements
Must be a U.S. Citizen or Green Card Holder.
No relocation or remote work supported.Preferred Qualifications (Nice to Have)
Prior experience with SAP or other ERP systems.
Experience working with solid oral dosage forms, liquids, tablets, and capsules.
Familiarity with equipment and materials used in pharmaceutical QA inspections.Benefits Package Includes:
401(k) plan with company match
Medical, Dental, and Vision insurance
Health Savings Account (HSA) and Flexible Spending Account (FSA)
Paid Time Off (Vacation, Sick, Flex Days) and Paid Holidays
Short-term and Long-term Disability coverage
Parental Leave
Employee discounts and more
Full-time