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, performing IPQA testing, ensuring equipment and area cleanliness, and maintaining SAP system records. The position also includes involvement in investigations of deviations and non-conformances, reviewing batch records and engineering data, and conducting daily quality rounds on the shop floor. The QA Inspector must ensure compliance with cGMP and SOPs, complete assigned training, and report 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.
Work standing or walking unassisted for 75% or greater of an 8-hour period.
Unassisted lifting up-to 35 lbs., may be required.
Able to wear appropriate personal protective equipment at all times, when required.

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

Monitoring and ensuring product quality through all phases of manufacturing or packaging in compliance with established specifications.
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.
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.
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).
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.