QC Analyst

Responsibilities

• Perform primary review of QC raw data and trend results
• Prepare protocols, summaries, and reports for pharmaceutical regulatory agencies
• Draft and update QC Standard Operating Procedures (SOPs)
• Act as a technical subject matter expert (SME) and provide training to other analysts
• Evaluate analytical and microbiological results against defined acceptance criteria
• Conduct and document laboratory investigations through to completion
• Maintain the laboratory in a constant state of audit and inspection readiness
• Interface with Manufacturing, Quality Assurance, and external contractors

Requirements

• BSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience, OR an MSc with 3+ years of relevant cGMP laboratory experience
• Experience with QC raw data review
• Ability to work a 4 cycle shift pattern to support continuous manufacturing
• Knowledge of SOP drafting and laboratory investigation documentation
• Strong written and verbal communication skills

Preferred Qualifications

• Experience in a 5S certified analytical laboratory environment
• Proven ability to work under pressure in a fast-paced GMP manufacturing setting
• Demonstrated success in a high-performing, team-oriented organization

About the Company

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams deliver revolutionary treatments for conditions such as achondroplasia, PKU, and various forms of MPS.