QA Associate/Sr QA Associate, External Quality en BioMarin Pharmaceutical Inc.

Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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.

• 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 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 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, external operations, etc.
• Independently identify and resolve lot issues with Contract Manufactures and Operations team
• Identify process discrepancies and implement process improvements to existing processes
• Work directly with BioMarin CMO, Supply Chain, Clinical Manufacturing, QC, and Regulatory Affairs to ensure lots are released to meet supply requirements.
• Provide QA decision, direction, and leadership in assigned interdepartmental meetings.
• Assist with regulatory inspections.
• Provide guidance for lower level personnel.
• Other duties as assigned.

• 6+ years of directly related experience in a GMP Quality or Manufacturing environment.
• Working knowledge of process and desktop computers. Proven comprehension of technical information and regulatory expectations.
• Strong attention to detail, organization and communication skills.
• Ability to maintain organization of a large volume of data in a systematic manner
• Proficiency with computer systems (Microsoft Office Suite).
• Proficiency with eQMS (TrackWise), LIMS, Oracle EBS, eCDMS (Veeva) and Office365 preferred.

• BA or BS in a technical discipline (physical or biological sciences preferred).
• Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical engineering, chemical or biological sciences) is required.
• Advanced degree 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, Operations, Pharm/Tox, Regulatory, R&D, Business Operations, Finance, Information Technology, and Administration.

• This position will not have supervisory responsibilities

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.