QA Specialist (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.
Prepare the site for GMP operations by supporting cross functional GMP readiness initiatives
Review and Approval of electronic and paper production batch records
Daily presence and support on the manufacturing floor
Release of Raw Materials for production.
Support the Technology Transfer of a new product into the site including raw material and supplier qualification.
Support quality systems on site.
Review and approve new or updates to standard operating procedures (SOPs) and master batch records.
Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
Review and approve Change Control documents
Assist with regulatory inspections.
Support the following activities, as appropriate: Engineering activities, RCARs, New or updates to relevant quality agreements, Process and Cleaning Validation activities, Continuous Improvement/Lean initiatives, Compile and present metrics. Other duties as assigned
Note: shift role. (6 week cycle including 1 week of earlies and 1 week of lates with 4 weeks of days.) Earlies = 6.30am-2.30pm, lates = 2.30pm-10.30pm).
Skills: Minimum 3 years' relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Compliance. Experience and ability to work cross functionally. Experience in supporting manufacturing operations, batch record review and deviation/CAPA is highly desirable. Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors. Ability to comprehend technical information related to equipment, processes, and regulatory expectations. Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
Education: Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences, pharmacy) is required.
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.