What are the responsibilities and job description for the QA Inspector position at Pharma Mfg. (Generic/ DPI/OSD)?
Job Title: QA Inspector I (1st & 2nd Shift)
Location: Hauppauge, New York
Employment Type: Full-Time | 1st Shift (7:00AM – 3:30PM) & 2nd Shift (3:00PM – 11:30PM)
Overview
We are seeking a QA Inspector I to join our team in Hauppauge, NY. The QA Inspector is responsible for ensuring compliance with cGMP, SOPs, and quality standards during all phases of pharmaceutical manufacturing and packaging. This position plays a critical role in verifying raw materials, in-process checks, and ensuring proper documentation to maintain product quality and patient safety.
Key Responsibilities:
- Verify raw materials during dispensing and issue printed packaging materials.
- Perform in-process checks during manufacturing and packaging per batch instructions.
- Collect in-process, finished product, and validation samples; conduct Blend Uniformity (BU) sampling.
- Clean and maintain sampling tools (rods, dies, sample boxes).
- Conduct IPQA testing (LOD, bulk density, tapped density, leak test, weight variation).
- Provide line clearance and ensure cleanliness of manufacturing & packaging equipment.
- Post materials and sample data in SAP (ERP) and perform related system transactions.
- Support deviation, OOS, OOT, or non-conformance investigations.
- Review online batch records, logbooks, calibration/PMP records.
- Ensure proper handling and accountability of rejected material.
- Participate in daily Quality rounds to ensure GMP compliance.
- Escalate discrepancies to QA Manager.
- Perform other duties as assigned by management.
Qualifications:
- Education: Minimum Science Graduate (Required)
- Experience: 1–2 years in pharmaceutical QA (DPI, MDI, or Injectables preferred; biopharma not considered)
- Knowledge: Strong understanding of cGMP, SOPs, and 21 CFR Part 820
- Technical Skills: SAP/ERP system experience preferred; MS Word, PowerPoint, Excel basics
- Soft Skills: Strong written/verbal communication, organization, attention to detail, ability to multitask
Benefits:
- 401(k) with 4% company match
- Health, Dental, and Vision Insurance
- Health Savings Account (HSA) & Flexible Spending Account (FSA)
- Paid Time Off (vacation, sick, flex days)
- Paid Holidays
- Short-term & Long-term Disability (STD/LTD)
- Life Insurance
- Parental Leave & Paid Family Leave
- Employee Discounts
Job Type: Full-time
Benefits:
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- How many years of experience in pharmaceuticals (DPI, MDI, or Injectables) do you have?
- Do you have experience working under cGMP and SOP compliance?
- Which shift(s) are you available to work (1st shift / 2nd shift / both)?
- Do you have experience with SAP or other ERP systems?
- Can you describe your experience with in-process quality checks (IPQA) in manufacturing?
- Have you been involved in deviation, OOS, or non-conformance investigations before?
- Please provide your expected hourly rate or base salary.
- Are you legally authorized to work in the United States (U.S. citizen/Green Card holder)?
- Please provide your email address and phone number for further communication.
Work Location: On the road