Job Description
Job DescriptionJob 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 Years
Job 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