Senior QA Validation Lead — Life Sciences Packaging

Regeneron Pharmaceuticals, Inc (USA)

United States

On-site

USD 67,400 - 128,700

Full time

14 days+

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Benefits offered by this job

Student loan paydown program & tuition

Family care benefits

Relocation assistance

Inclusion, culture and well-being

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Sr. QA Validation Specialist to validate/qualify equipment, systems, and processes in line with regulatory requirements. You will support manufacturing standards and procedures within a fast-growing, science-driven organization based in Rensselaer, NY, with a Monday–Friday schedule.

The role requires a B.S. in life sciences (or equivalent) and 4+ years (Sr. 6+ years) of QA validation experience, plus responsibility for deviation investigations, change

Qualifications

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 qualification and validation protocols and reports.
Analyzes test results against predetermined criteria and documents outcomes.
Investigates problems and proposes solutions or improvements.
Reviews and approves deviation notifications, investigations, and corrective actions.
Coordinates with other departments or vendors to complete validation tasks.
Performs temperature mapping, packaging qualification, and cold-chain testing.

Skills

QA Validation

Qualification

Deviation handling

Change controls

Documentation

Education

Bachelor's degree in Life Sciences

Job description

The role requires a B.S. in life sciences (or equivalent) and 4+ years (Sr. 6+ years) of QA validation experience, plus responsibility for deviation investigations, change

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