QA Inspector II

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

The QA Inspector II will report directly to the QA Supervisor or QA Manager.

Job Responsibilities

• This role is responsible for the oversight of all daily QA inspection activities, of finished products and sub-assemblies.


• This role is expected to model our Leadership Behaviors-Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results-in all aspects of work. Performs in-process finished goods and final inspection including visual inspection.


• Verification of components to engineering records and documentation requirements.


• Access and interpret engineering drawings, bill of materials, specifications, 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.

Qualifications

• High School Diploma, GED, or equivalent with 3 to 5 years of Quality Inspection required.


• Laboratory or manufacturing setting work experience within a controlled Quality environment preferred.


• Ability to work independently once training has been completed.


• Ability to communicate with multiple departments.


• Detail oriented to all aspects of daily activities.


• Experience with ISO 9001, ISO 13485, 21CFR820 or equivalent QMS standards.


• Maintain a positive and team-oriented attitude with good organizational skills.


• Good written and verbal communication skills.


• Knowledge of AQL Inspection Plans

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated hourly rate for this role, based in the United States of America is between $20.80/Hr - $29.90/Hr. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. All compensation and benefits information will be confirmed in writing at the time of offer.

Benefits

• paid time off


• health/dental/vision


• retirement benefits


• flexible spending accounts