Senior QA Specialist, Drug Product Start-Up Lead

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Student loan paydown

Family care benefits

Relocation assistance

Equity awards

Health & wellness

Job summary

Regeneron Pharmaceuticals, Inc (USA) in East Greenbush, New York, is seeking a Senior Quality Assurance (QA) Specialist to join the QA Drug Product team on the 3rd shift, Friday–Tuesday, 10:00 p.m.–8:30 a.m.

The role focuses on establishing new start-up programs for drug product operations, authoring and approving SOPs and batch documentation, mentoring on-the-floor manufacturing, and supporting audits, inspections, and investigations in a fast-growing, science-driven company.

Qualifications

• B.S in life sciences or related field.
• 6+ years of QA experience in pharmaceutical setting.
• Experience with SOPs, batch records and regulatory documents.

Responsibilities

• Lead start-up of formulation, filling, inspection, assembly, and pack/label operations.
• Develop, write, review, and approve SOPs, specifications and documents.
• Maintain project timelines for evolving business needs.
• Mentor on-the-floor manufacturing and support audits/inspections.

Skills

QA experience

Pharma manufacturing

Documentation review

Education

Bachelor's degree in life sciences

Job description

Regeneron Pharmaceuticals, Inc (USA) in East Greenbush, New York, is seeking a Senior Quality Assurance (QA) Specialist to join the QA Drug Product team on the 3rd shift, Friday–Tuesday, 10:00 p.m.–8:30 a.m.

The role focuses on establishing new start-up programs for drug product operations, authoring and approving SOPs and batch documentation, mentoring on-the-floor manufacturing, and supporting audits, inspections, and investigations in a fast-growing, science-driven company.