QA Inspector I - DPI

CIPLA LTD•Hauppauge, NY

47d•$17 - $23•Onsite

About The Position

The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing and packaging in compliance with established procedures

Requirements

Minimum Science Graduate
Minimum 1-2 years' experience in pharmaceuticals (DPI, MDI or Injectables preferred).
Knowledge of Good Manufacturing Practices and 21 CFR Part 820.
Ability to read, write and communicate effectively.
Self-motivated, with the ability to work in a fast-paced manufacturing environment and handle multiple tasks simultaneously.
Excellent organization skills with the ability to focus on details
Basic computer skills (Microsoft Word, Power and Excel).

Responsibilities

Verification of raw materials during the dispensing process.
Dispensing printed packaging materials to packaging.
Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging record instructions.
Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, to perform blend uniformity (BU) sampling.
To clean and maintain the samplings rods/dies/sample boxes used for BU sampling.
Perform IPQA testing on the manufacturing floor specifically LOD, Bulk Density, Tapped Density, Leak Test, Weight Variation test.
Ensure cleaning of manufacturing and packaging equipment, area and provide line clearance.
To perform posting of dispensed materials and samples into SAP system (ERP system) and to perform other transactions in SAP.
Involve in investigation of Deviation, OOS, OOT, or any other non-conformances.
Ensure completion of individual training assigned and follow company policies, safety requirements, cGMP and SOP's.
Review of online batch records, area/equipment logbooks, calibration/PMP records etc.
Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
Review of engineering records (temperature and humidity data, calibration reports and PMP records).
To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement.
Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.
Other duties [additional support] that management may assign from time to time.

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid family leave, employee discounts, and other benefits.

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