
QA Inspector I
- Central Islip, NY
- Permanent
- Full-time
- 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.
- 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).