Quality Assurance Investigator (TEMPORARY)
Location San Rafael, California Apply
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.
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.
Apply 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.
Duties
The Quality Assurance Systems Investigator is responsible for writing investigation summaries and performing root cause analysis and potential impact to systems, facilities and product.
The position requires some technical writing skills.
- Participate in activities related to core quality systems
- Deviations, Alert, Action, Laboratory Investigations and CAPA’s
- Document Control
- Internal Audit
- Liaise with Novato colleagues to aid in harmonization of Global Quality functions and systems
Skills
Competencies Required
Behavioural
- Accountability
- Achieving Excellence
- Communication
- Develop Self & Others
- Judgement
- Reliability
- Teamwork
Technical
- Technical Knowledge
- Analytical Thinking & Problem-Solving
- Compliance
- Documentation
- Workload & Time Management
Education
Education Required
- B.S. or BA in a science related field.
Experience Required
- 1+ years’ experience in a cGMP or GLP related field, or laboratory.
- Ability to speak, present data, and defend approaches in front of audiences
- Ability to comprehend technical information
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.
