DPI QA Inspector II

Job Title: DPI QA Inspector II

Location: Hauppauge, NY (On-site only)

Employment Type: Full-Time

Shift: General (8:30 AM – 5:00 PM; may vary depending on business needs)

Experience Required: 3 – 15 Years

Job Summary:

A pharmaceutical manufacturing facility is seeking a QA Inspector II to ensure that product quality is maintained throughout all phases of manufacturing and packaging. This role involves in-process checks, sampling, and equipment clearance in compliance with cGMP and regulatory standards.

Key Responsibilities:

Perform verification of raw materials during dispensing.

Dispense printed packaging materials to the packaging department.

Conduct in-process checks during batch manufacturing and packaging per batch records.

Collect samples for in-process blend, finished product, validation, and blend uniformity (BU) testing.

Clean and maintain BU sampling equipment such as rods, dies, and boxes.

Execute floor-level quality testing: LOD, bulk density, tapped density, leak test, weight variation, etc.

Ensure cleanliness of manufacturing/packaging equipment and provide line clearance.

Enter dispensed materials and sample data into SAP (ERP system) and complete related transactions.

Participate in investigations of deviations, OOS (Out of Specification), OOT (Out of Trend), and other non-conformances.

Complete required training and adhere to company policies, safety regulations, cGMP, and SOPs.

Review online batch records, equipment logbooks, calibration and preventive maintenance records.

Ensure proper handling and documentation of rejected materials during batch processes.

Review temperature, humidity, calibration, and maintenance records for compliance.

Conduct daily quality rounds on the shop floor to ensure compliance and GMP readiness.

Escalate discrepancies and key findings to Quality Assurance Management.

Support other duties as assigned by QA leadership.

Required Qualifications:

High School Diploma or educational equivalent with strong science background.

Minimum 1–2 years of experience in pharmaceutical manufacturing (preferred: DPI, MDI, or Injectables).

Experience with GMP regulations and 21 CFR Part 820.

Ability to read, write, and communicate clearly and professionally.

Proficiency with Microsoft Office (Word, Excel, PowerPoint).

Strong mathematical skills and attention to detail.

Ability to manage multiple tasks in a fast-paced, regulated environment.

Self-motivated with excellent organizational skills.

Physical & Work Environment Requirements:

Must be able to stand or walk unassisted for 75% or more of an 8-hour shift.

Must be able to lift up to 35 lbs unassisted.

Must wear appropriate PPE (e.g., lab coat, gloves, safety glasses, respiratory protection) when required.

Work is performed in a GMP-controlled manufacturing or laboratory environment.

Exposure to powders, solvents, and standard pharmaceutical production materials is expected.

Remote work and relocation are not supported for this position.

Benefits:

Health Insurance – Medical, Dental, Vision (including HSA & FSA options)

401(k) Savings Plan with Company Match

Paid Time Off (PTO) – Vacation, Sick, Flex Time

Paid Holidays

Short-Term & Long-Term Disability Insurance

Parental Leave

Employee Discounts

Additional benefits in alignment with company policy