Associate 1/2, QA Operations
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients’ lives.
This position reports to the Quality Assurance Operations Manager and is responsible for quality oversight of one or more processes relating to make, assess, and release for products manufactured at the BioMarin Novato site.
The ideal candidate will have strong organization and communication skills with a background in biopharmaceutical manufacturing, quality control, and/or quality systems.
- Provide quality oversight of one or more portions of operations including, but not limited to; review of documentation, change requests, batch record and associated documentation review, deviation/CAPA review, and product changeover oversight.
- Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.
- Provide status reports, including relevant metrics, to department management.
- 5+ years of experience in a GMP regulated environment.
- Proven valued team member, with the ability to work independently on tasks.
- Proven comprehension of technical information and regulatory expectations.
- Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus).
- Exhibited proficiency working within quality systems.
- Ability to successfully communicate with representatives from all levels within the organization.
- Experience and proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point.
- Experience with TrackWise, Livelink, Veeva Vault, Oracle systems a plus.
- BA or BS in a technical discipline (physical or biological sciences preferred).
- This position does not utilize any specific equipment.
This position will require interaction with all levels (up to Senior/Executive Management) in Technical Operations, Clinical Operations, Pharm/Tox, Regulatory, R&D, Business Operations, Finance, Information Technology, and Administration.
This position will not have supervisory responsibilities.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.