Process Sciences Quality & Compliance Specialist

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 62,000 - 92,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Regeneron Pharmaceuticals, Inc (USA) is seeking an individual to support Process Sciences by overseeing all aspects of cGMP compliance and quality records. The role emphasizes coordination across departments, training on technical writing, and maintaining key quality metrics.

The position values experience with change controls, CAPAs, and supplier notifications, with emphasis on consistent records and proactive compliance in a fast-paced biotech environment.

Qualifications

• Assoc: BS/BA in scientific discipline or related field with 0-2+ years industry experience; or equivalent combination of education and experience.
• Int: BS/BA in scientific discipline or related field with 2+ years industry experience; or equivalent combination of education and experience.
• Sr: BS/BA in scientific discipline or related field with 5+ years industry experience; or equivalent combination of education and experience.

Responsibilities

• Execute, monitor, and track progress of Process Sciences owned quality records, such as Change controls, supplier notifications and CAPAs.
• Be a SME for quality records and quality systems, ensuring consistency of records.
• Train and promote technical writing and quality awareness.
• Maintain and communicate appropriate metrics.
• Review department owned quality records for compliance and accuracy.
• Strong communicator to represent Process Sciences at daily & weekly cross functional meetings.
• Act as a liaison for coordination of changes between the Process Sciences department and other departments.
• Drive proactive compliance environment in the Process Sciences department through knowledge transfer and education of compliance related items.

Skills

Quality records

Quality systems

Technical writing

Metrics communication

Cross-functional collaboration

Education

Assoc/BS in scientific discipline

Int BS/BA in scientific discipline

Sr BS/BA with 5+ years

Job description

Regeneron Pharmaceuticals, Inc (USA) is seeking an individual to support Process Sciences by overseeing all aspects of cGMP compliance and quality records. The role emphasizes coordination across departments, training on technical writing, and maintaining key quality metrics.

The position values experience with change controls, CAPAs, and supplier notifications, with emphasis on consistent records and proactive compliance in a fast-paced biotech environment.