QA Inspector II: Drive Bioprocess Quality & Compliance

RepliGen Corporation; California; Vor Ort; USD 29.000 - 41.000; Vollzeit

Benefits dieser Stelle

Paid time off

Health/dental/vision

Retirement benefits

Flexible spending accounts

Zusammenfassung

RepliGen Corporation in California is seeking a QA Inspector II to oversee daily QA inspection activities for finished products and sub-assemblies. You will verify components to engineering records, read drawings, BOMs, specs, and purchase orders to determine quality status and support manufacturing.

Responsibilities include reviewing batch records, training new hires, communicating nonconformances, using QA software, and ensuring compliance with ISO 9001/13485 standards.

Qualifikationen

• High School Diploma or GED with 3–5 years in Quality Inspection.
• Experience in laboratory or manufacturing quality environments.
• Ability to work independently after training.
• Ability to communicate with multiple departments.
• Detail oriented with careful documentation.
• Familiarity with ISO 9001, ISO 13485, 21 CFR 820.
• Strong organizational skills and teamwork.
• Knowledge of AQL Inspection Plans.

Aufgaben

• Performs in-process finished goods and final inspection including visual inspection.
• Verify components to engineering records and documentation requirements.
• Access and interpret engineering drawings, BOMs, specs, and purchase orders to determine quality status and support manufacturing.
• Prepare, print, and verify documentation and labels for quality and manufacturing process.
• Review manufacturing batch records against applicable quality requirements and document results of inspections.
• Train new hires.
• Identify and clearly communicate nonconformances to specified requirements to Management in timely manner.
• Proficiently use applicable software to accurately document and maintain the QA inspection process.
• Support completed batch records scanning and records retention.
• Initiate NCMRs for non-conforming materials and assist in investigations for deviations, CA, etc.
• Ensure compliance to current SOP’s and Work Instructions and suggest enhancements to procedures.
• Review Lot History Records (LHR) for release of finished products and sub-assemblies in SAP.
• Adhere to all company Quality policies and procedures.

Kenntnisse

Detail oriented

Interdepartmental comms

Independent worker

ISO standards

AQL Plans

Ausbildung

High School Diploma or GED

Jobbeschreibung

RepliGen Corporation in California is seeking a QA Inspector II to oversee daily QA inspection activities for finished products and sub-assemblies. You will verify components to engineering records, read drawings, BOMs, specs, and purchase orders to determine quality status and support manufacturing.

Responsibilities include reviewing batch records, training new hires, communicating nonconformances, using QA software, and ensuring compliance with ISO 9001/13485 standards.