Senior QA Validation Specialist - Lead & Compliance

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 67,000 - 129,000; Full time

Benefits offered by this job

Bonuses

Pension or retirement benefits

Health and wellness programs

401(k) company match

Paid time off

Job summary

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY is seeking a QA Validation Specialist to generate, execute and review master and completed qualification protocols and validation reports, ensuring conformance to regulations and SOPs.

The role analyzes testing results, investigates issues, coordinates with departments and vendors, and trains junior staff while managing projects. Responsibilities include overseeing transport studies, temperature mapping, sensor programming and data analysis, and

Qualifications

• Requires B.S in life sciences or related field; may substitute proven experience for education requirement.
• QA Validation Specialist: 4+ years of experience.
• Sr. QA Validation Specialist: 6+ years of experience.

Responsibilities

• Generates, executes and reviews master and completed qualification and validation protocols, summary reports and associated data.
• Analyzes testing results for conformance to criteria.
• Investigates and troubleshoots problems and recommends solutions.
• Reviews deviation notifications, investigations, and corrective actions.
• Reviews change controls, SOPs, and other documentation.
• Coordinates with other departments or vendors to complete validation tasks.
• Trains/advises less experienced Specialists; manages projects and status reports.
• Oversees contingent workers when required.
• Executes real-world and simulated transport studies; performs temperature mapping.
• Programs and deploys instrumentation to capture vibration, humidity, and pressure data.
• Applies ASTM and ISTA standards to cold-chain shipping design and testing.
• Performs small-parcel and palletized-load qualifications and reporting.

Skills

QA Validation

Validation Specialist

Data analysis

Problem solving

Project management

Training

Team leadership

Gowning & cleanroom

Education

B.S. Life Sciences

Job description

Regeneron Pharmaceuticals, Inc. in Rensselaer, NY is seeking a QA Validation Specialist to generate, execute and review master and completed qualification protocols and validation reports, ensuring conformance to regulations and SOPs.

The role analyzes testing results, investigates issues, coordinates with departments and vendors, and trains junior staff while managing projects. Responsibilities include overseeing transport studies, temperature mapping, sensor programming and data analysis, and