QA Inspector I

Cipla•Hauppauge, NY

11d•$17 - $23•Onsite

About The Position

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

Requirements

Knowledge of Good Manufacturing Practices and Good Documentation Practices.
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).
Minimum High school diploma.
Minimum 1-2 years’ experience in manufacturing or packaging pharmaceuticals.

Responsibilities

Verification of raw materials during the dispensing process.
To perform posting of dispensed materials and samples into SAP system and to perform other transactions in SAP.
Maintenance of standard weights and perform daily verification of balances
Perform in-process checks during batch manufacturing, as per manufacturing record instructions.
Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, to perform blend uniformity sampling.
Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
Ensure cleaning of manufacturing and equipment, area and provide line clearance.
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.
Perform AQL, Blend sampling, In-process Sampling, and inspections as required.