QA Inspector II - Bioprocess Quality & Compliance

Regulatory Jobs; California; On-site; USD 29,000 - 41,000; Full time

Benefits offered by this job

Health benefits

Paid time off

Retirement benefits

Flexible spending accounts

Job summary

Regulatory Jobs in California seeks a QA Inspector II to oversee daily QA inspection activities for finished goods and sub-assemblies. You will review lot history, execute in-process and final inspections, interpret drawings, and ensure compliance with SOPs and QMS standards. Experience with ISO 9001/13485 and SAP is preferred.

Strong communication and detail orientation are essential as you train new hires and report findings to management.

Qualifications

• 3 to 5 years of Quality Inspection in lab or manufacturing.
• Ability to work independently after training.
• Experience with ISO 9001, ISO 13485, 21CFR820 or equivalent QMS standards.
• Detail oriented and good communication skills.
• Knowledge of AQL Inspection Plans.

Responsibilities

• In-process finished goods and final inspection including visual inspection.
• Verify components to engineering records and docs requirements.
• Interpret drawings, BOMs, specs, and purchase orders to determine quality status.
• Prepare, print, and verify documentation and labels for QA and manufacturing.
• Review batch records against quality requirements and document results.
• Train new hires and communicate nonconformances to management.
• Use QA software to document and maintain inspection process.
• Support batch records scanning and records retention.
• Initiate NCMRs for non-conforming materials and assist investigations.
• Ensure SOPs and work instructions compliance and suggest improvements.
• Review Lot History Records (LHR) for release in SAP.
• Adhere to quality policies and procedures.

Job description

Regulatory Jobs in California seeks a QA Inspector II to oversee daily QA inspection activities for finished goods and sub-assemblies. You will review lot history, execute in-process and final inspections, interpret drawings, and ensure compliance with SOPs and QMS standards. Experience with ISO 9001/13485 and SAP is preferred.

Strong communication and detail orientation are essential as you train new hires and report findings to management.