Sr. Quality Assurance Specialist
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.
***Role is currently remote, but will need to be able to come onsite once restrictions lift***
The External Quality Senior Sr Specialist is responsible for quality oversight for the production of clinical and commercial fill and pack manufacturing processes related to the Contract Manufacturing Organizations (CMOs) and release of lots. The Sr Specialist interacts with GEO, CMO, Quality Control, Regulatory Affairs, Planning/Supply Chain and CMC.
- Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.
- Support development of commercial and clinical GMP systems at BioMarin.
- Assist with driving implementation of a science and risk-based Quality Culture throughout the External Quality team.
- Provide quality oversight of external commercial and clinical CMO’s for those products and services as licensed by the HPRA and FDA, as supervisory authority.
- 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 lot release. This involves coordination with other groups such as supply chain, CMO, CMO Pack Ops, etc.
- Work directly with BioMarin CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs to ensure lots are released to meet supply requirements.
- Conduct lot assessments for product complaints.
- Assist with QA decision, direction, and leadership in assigned interdepartmental meetings.
- Assist with regulatory inspections.
- Implement continuous process improvements.
- Other duties as assigned.
3-5 Years Exp with Degree
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.