Quality Compliance Specialist (Change Controls)

Regeneron Pharmaceuticals, Inc.; City of Rensselaer (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

Scorpion Therapeutics in New York is seeking a Quality Compliance Specialist focused on change control activities within a biopharma cGMP environment. You will review, assess, and approve change control documentation and support cross-functional teams.

The role requires a BS in life sciences or related field, 0-2+ years for Associate, 2+ years for Specialist, and proficiency with MS Office; experience with Veeva/QMS is a plus. Based in Rensselaer, NY, Monday–Friday, 8am–4:30pm.

Qualifications

• BS in life sciences or related field (or equivalent experience).
• 0-2+ years for Associate level, 2+ years for Specialist.
• Proficiency in MS Word, Excel, PowerPoint. experience with Veeva/QMS is a plus.

Responsibilities

• Review, assess, and approve change control documentation ensuring compliance with quality, regulatory, and SOP standards.
• Facilitate cross-functional meetings and guide change owners; partner with QA colleagues and system users to enhance change control systems and procedures.

Skills

MS Word

Excel

PowerPoint

Education

BS in life sciences or related field

Tools

Veeva

QMS

Job description

Role

Quality Compliance Specialist focusing on change control activities within a biopharma cGMP environment.

Responsibilities

review, assess, and approve change control documentation ensuring compliance with quality, regulatory, and SOP standards; facilitate cross-functional meetings and guide change owners; partner with QA colleagues and system users to enhance change control systems and procedures; interpret compliance/regulatory requirements for system implementation; support audits as a subject matter expert; leverage knowledge of biotech/pharmaceutical quality systems, FDA regulations, ICH guidelines, and global standards.

Requirements

B.S. in life sciences or related field (or equivalent experience); 0-2+ years for Associate level, 2+ years for Specialist; proficiency in MS Word, Excel, PowerPoint; experience with Veeva/QMS a plus.

Location & Hours

Based in Rensselaer, NY, working Monday-Friday, 8am-4:30pm.

High-Value & Collaboration

Focus on internal change controls, cGMP compliance, FDA and international regulations, biotech/pharma quality systems, with the position based in Rensselaer, NY, working Monday-Friday, 8am-4:30pm. Collaboration: partner with QA and system end users; support audits and continuous improvement initiatives.