QA Inspector II - DPI

Cipla•Hauppauge, NY

4h•Onsite

About The Position

The QA Inspector is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications. This role involves verification of raw materials, performing in-process checks, collecting samples for analysis, and ensuring equipment and areas are clean and properly cleared. The inspector will also be responsible for data entry into SAP, participating in investigations of deviations, and reviewing various quality-related records. Additionally, the role requires daily quality rounds on the shop floor to ensure compliance with GMP requirements and reporting any discrepancies to management.

Requirements

Minimum Science Graduate
Knowledge of Good Manufacturing Practices and 21 CFR Part 820.
Ability to read, write and communicate effectively.
Basic computer skills (Microsoft Word, Power and Excel).
Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously.
Excellent organization skills with strong attention to details skills.
Strong fundamental mathematical skills and knowledge.

Nice To Haves

A minimum of 1-2 years of pharmaceutical experience (DPI, MDI or Injectables) preferred.
Preference will be given to candidates with experience in generic pharmaceutical manufacturing.

Responsibilities

Monitor and ensure product quality is maintained through all phases of manufacturing or packaging in compliance with established specifications.
Verify raw materials during the dispensing process.
Dispense printed packaging materials to packaging.
Perform in-process checks during batch manufacturing and packaging, as per manufacturing & batch packaging record instructions.
Collect in-process blend, finished product, and validation samples for analysis, and sample collection as per protocols.
Perform blend uniformity (BU) sampling.
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.
Post dispensed materials and samples into SAP system (ERP system) and 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 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 engineering records (temperature and humidity data, calibration reports and PMP records).
Take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement.
Report and escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.
Perform other duties that management may assign from time to time.