QC Sample Management Specialist

Who We Are

BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

• Perform Sample Management aspects (Sample receipt, control, and disposal of samples)
• Perform Stability and Reference Standard study/protocol generation
• Perform stability and reference standard pulls
• Maintain stability, lot release, reserve, retention sample inventory
• Perform preventative maintenance on stability/sample chambers.
• Perform domestic and international shipments of samples and critical materials
• Interacts with other departments at BioMarin on a regular basis
• Participation in laboratory project initiatives such as 5S, LEAN, and Six Sigma
• Participate in inspection readiness, regulatory inspection support and self-inspection activities.
• Perform Quality System attributes such as but not limited to (i.e. Minor Deviations, CAPAs, Change Controls, Action Items)
• Other duties as assigned

• At least one year in a cGMP/GLP laboratory; quality control experience is preferred.
• Ability to follow written instructions and to perform tasks with direct or minimal supervision.
• Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Demonstrates the ability to work independently.

Education Required

• A.S./B.A. in Science (major in biology-biochemistry-chemistry).
• 1-2 years of relevant laboratory experience or A.S. with at least 4 years of relevant laboratory experience is desired.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.