QC Analyst

Responsibilities

• Perform primary review of QC raw data and trend results
• Prepare protocols, summaries, and reports for regulatory submission
• 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 Facilities departments

Requirements

• BSc in a scientific or engineering discipline with 5+ years of cGMP laboratory experience, or an MSc with 3+ years of cGMP laboratory experience
• Proven experience with the primary review of QC raw data
• Demonstrated ability to draft and update QC SOPs
• Experience conducting and documenting laboratory investigations
• Ability to work within a 4-cycle shift pattern to support continuous manufacturing

Preferred Qualifications

• Experience working in a 5S-certified analytical laboratory environment
• Strong written and verbal communication skills
• Ability to thrive in a fast-paced, highly compliant GMP manufacturing environment

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.