QA Inspector II - Quality Compliance & Process Guardian

Repligen Corp; California; On-site; USD 29,000 - 41,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corp in California is seeking a QA Inspector II to oversee daily QA inspection activities for finished products and sub-assemblies. The role requires 3–5 years in quality inspection and familiarity with ISO 9001, ISO 13485, and 21 CFR 820, with SAP experience for batch records.

You will train new hires, communicate nonconformances to management, and ensure compliance with SOPs and WIs, contributing to product quality across manufacturing processes.

Qualifications

• 3–5 years of Quality Inspection experience required.
• Experience in laboratory or manufacturing quality environments preferred.
• Ability to work independently after training.
• Strong communication across departments.
• Detail oriented in daily QA activities.
• Familiarity with ISO 9001, ISO 13485, and 21 CFR 820 or equivalent QMS.
• Knowledge of AQL Inspection Plans.

Responsibilities

• Oversight of daily QA inspection activities for finished products and sub-assemblies.
• Model Leadership Behaviors: Integrity, Customer Focus, Collaboration, Courage, Team Empowerment, Accountability & Results.
• Perform in-process, finished goods, and final inspections including visual checks.
• Verify components against engineering drawings and documentation.
• Interpret BOMs, specifications, and POs to determine quality status.
• Prepare and verify QA documentation and labels.
• Review batch records against quality requirements and document results.
• Train new hires.
• Identify nonconformances and escalate to Management promptly.
• Use QA software to document the inspection process.
• Support batch records scanning and records retention.
• Initiate NCMRs for non-conforming materials and assist investigations.
• Ensure SOP and Work Instruction compliance; suggest enhancements.
• Review LHR for release of finished products in SAP.
• Adhere to all Quality policies and procedures.

Skills

Attention to detail

Independent worker

Communication skills

ISO 9001 knowledge

ISO 13485 knowledge

21 CFR 820 knowledge

SAP usage

AQL inspection plans

Education

High School Diploma / GED

Tools

SAP

Job description

Repligen Corp in California is seeking a QA Inspector II to oversee daily QA inspection activities for finished products and sub-assemblies. The role requires 3–5 years in quality inspection and familiarity with ISO 9001, ISO 13485, and 21 CFR 820, with SAP experience for batch records.

You will train new hires, communicate nonconformances to management, and ensure compliance with SOPs and WIs, contributing to product quality across manufacturing processes.