Senior Quality Engineer, Bioprocess & Compliance

RepliGen Corporation; California; On-site; USD 115,000 - 155,000; Full time

Job summary

RepliGen Corporation in Rancho Dominguez, CA seeks a Senior Quality Engineer to partner across Manufacturing, Engineering, Operations, Supply Chain, and R&D to ensure high-quality biologics products. You will lead investigations, CAPA, and QA initiatives from concept through implementation.

The role emphasizes data-driven decisions, cross-functional collaboration, and ongoing quality improvements. It requires strong technical communication and the ability to influence outcomes in a regulated

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 7+ years of Quality/Manufacturing Engineering in regulated environment.
• Working knowledge of quality systems and regulatory requirements.
• Experience with investigative methodologies, RCA, CAPA, auditing, and statistical data analysis.
• Strong data analysis and communication across technical audiences.
• Proficiency with Microsoft Office; familiarity with eQMS like MasterControl preferred.
• Experience with regulated industries (biologics, pharma) preferred.
• CQE/CQA or Lead Auditor certifications are a plus.
• Ability to work in office and manufacturing/lab environments, incl. lifting up to 25 lbs.

Responsibilities

• Lead investigations and root-cause analysis for manufacturing and R&D projects.
• Perform FMEA, RCA, Gauge R&R, and process control activities.
• Monitor metrology/calibration to meet quality objectives.
• Prepare quality and inspection plans and product specs.
• Conduct testing, qualifications, data analysis; suggest improvements.
• Review manufacturing plans for quality requirements and risk.
• Document critical QC points across processes.
• Lead CAPA and track corrective actions to closure.
• Prepare reports for customer complaints and ensure timely resolution.
• Assist audits (ISO, internal, customer) and drive improvement.
• Prepare quality agreements and supplier evaluations.
• Support process/Product improvement projects and design reviews.
• Deliver ISO, GDP training to promote quality awareness.
• Build relationships with customers and suppliers; liaison with Eng/Manufacturing.
• May serve as Lab Safety Coordinator.

Skills

Root cause analysis

CAPA

Process validation

Statistical data analysis

FMEA

Auditing

Education

Bachelor’s degree in Engineering or related field

ASQ CQE / CQA certification (plus)

Tools

MasterControl (eQMS)

Job description

RepliGen Corporation in Rancho Dominguez, CA seeks a Senior Quality Engineer to partner across Manufacturing, Engineering, Operations, Supply Chain, and R&D to ensure high-quality biologics products. You will lead investigations, CAPA, and QA initiatives from concept through implementation.

The role emphasizes data-driven decisions, cross-functional collaboration, and ongoing quality improvements. It requires strong technical communication and the ability to influence outcomes in a regulated