Product Specification Specialist
Core
Create, revise, and manage Product Specification Documents to ensure compliance with regulatory filings and site procedures in biopharmaceutical operations.
Role type
Quality Specialist (Product Specification)
Builds
Product Specification Documents and quality risk assessments
Domain
Biopharmaceuticals / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory compliance knowledge, Quality Risk Management, Deviation investigation, Cross-functional collaboration, Document lifecycle management, USP/EP compendia knowledge, ICH guidelines knowledge
Preferred skills
Biopharmaceutical testing or manufacturing experience
Responsibilities
Initiate, revise, and retire product specifications; Collaborate cross-functionally to define content for new and revised Product Specification Documents; Conduct Quality Risk Management assessments; Support deviation investigations involving product specifications; Identify project issues and contribute to alternative approaches; Participate in cross-functional meetings
Seniority
Associate (0-2 years), Specialist (2+ years), Senior (5+ years)
