Senior Specialist, Quality Assurance Program Management

Job overview

The Senior Specialist, Quality Assurance Program Management role is onsite in East Syracuse, NY. Compensation is $60,000–$88,000 per year, with a target bonus of 8%. LOTTE BIOLOGICS’ stated mission is to reliably deliver benefits for patients worldwide through quality and continuous innovation. The role executes and supports client-related quality assurance activities in a cGMP-regulated contract development and manufacturing organization environment. It provides quality oversight for product introductions, technical transfers, and lifecycle management, helping ensure work aligns with site procedures, client requirements, Quality Agreements, and applicable standards.

What you'll do

• Execute assigned QA activities for new product introductions, technical transfers, and lifecycle management
• review documentation for alignment with Quality Agreements, site procedures, and client requirements
• draft, review, and maintain Quality Agreements
• support audit readiness and serve as a QA representative when assigned
• drive client-specific change controls
• review deviations and CAPAs
• support Annual Product Quality Reviews
• review NPI and process validation documentation
• provide manufacturing quality oversight
• collaborate with cross-functional teams.

What we're looking for

Skills & competencies

quality assurance

program management

cgmp

biotechnology

pharmaceutical quality

quality agreements

deviations

capa

change control

new product introduction

east syracuse ny

lotte biologics

$60k–$88k per year

less than 5% travel

Work arrangement

• Weekend coverage required

Why this role

The position requires less than 5% travel and routinely includes oversight in laboratory, warehouse, dispensary, and manufacturing-floor environments, with appropriate PPE or gowning as required.

About the employer

LOTTE BIOLOGICS USA, LLC is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.