Senior Specialist, Quality Assurance Laboratory Operations

Role responsibilities

The Senior Specialist will provide quality oversight to manufacturing, quality control, and warehouse operations, ensuring compliance with policies and standards. They will monitor process performance, approve quality records, and lead cross-functional meetings.

Requirements

Candidates should have a bachelor's degree in a STEM field or equivalent experience, along with 4+ years of relevant cGMP experience. Proficiency in quality management systems and familiarity with FDA/EMA regulations in biopharmaceuticals is preferred.

Key skills

Quality Assurance, Data Analysis, Regulatory Compliance, Communication, Critical Thinking, Problem Solving, Team Leadership, Quality Management Systems, GxP, Manufacturing, Change Control, Deviation Management, Training, Risk Assessment, Project Management, Digital Tools

Keywords

Quality Assurance, cGMP, Manufacturing, Quality Control, Deviation Management, Change Control, Risk Assessment, Data Analysis, GxP, FDA Regulations, EMA Regulations, Project Management, Digital Tools, Training, Team Leadership, Communication