QA Inspector I - 2nd Shift | GMP Quality

Cipla

Fall River (MA)

On-site

USD 32,000 - 41,000

Full time

13 days ago

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Job summary

Cipla is seeking a QA Inspector I for the 2nd shift in Fall River, MA. The role focuses on monitoring product quality throughout manufacturing to ensure adherence to SOPs and specifications within a GMP environment.

Reporting to the Quality Assurance Manager, this individual contributor position requires in-process testing, documentation, and collaboration with QC/QA teams. A minimum high school diploma and 2+ years of QA experience in GMP pharma are expected.

Qualifications

  • Minimum high school diploma.
  • Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field preferred.
  • Minimum of two (2) years’ experience in quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
  • Experience in MDI preferred.

Responsibilities

  • Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
  • Conduct room and equipment checks prior to each stage of manufacturing by following detailed written procedures.
  • Execute acceptable quality limit (AQL) sampling and inspections as required.
  • Inspect in-process and finished product samples for the QC Lab and follow detailed documentation procedures to deliver the results to the QC Lab.
  • Maintain records of standard weights and perform daily verification of balances.
  • Ensure proper isolation of rejected material generated during batch process and accountability in the batch record.
  • Monitor facility and product environmental operating conditions.
  • Review engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions.
  • Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
  • Verify the functionality of all the equipment and associated controls during the batch run.
  • Perform applicable testing and prepare reports for customer complaints.
  • Identify and report any non-conformances and/or discrepancies to management if applicable.
  • Complete other duties or participate in project work as assigned by management.

Skills

MS Office
Attention to detail
Teamwork
Communication skills
cGMP knowledge

Education

High school diploma
Pharmaceutical manufacturing education preferred

Tools

SAP

Job description

Cipla is seeking a QA Inspector I for the 2nd shift in Fall River, MA. The role focuses on monitoring product quality throughout manufacturing to ensure adherence to SOPs and specifications within a GMP environment.

Reporting to the Quality Assurance Manager, this individual contributor position requires in-process testing, documentation, and collaboration with QC/QA teams. A minimum high school diploma and 2+ years of QA experience in GMP pharma are expected.

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