(CW) QC Sample Specialist ( Contract/Temporary)

United States·Novatomid

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Who We Are

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 have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

CONTRACT UP TO 1 YEAR Onsite 5 days per week in Novato***

Role Responsibilities
• 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
Note: The QC Sample Management Specialist may be required to work on BioMarin holidays and/or scheduled manufacturing shut down operations to support business needs.

Experience Required
• 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.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.

Ireland Safety Responsibility
Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.