QC Analyst - In Process

BioMarin

Cork
Permanent
Full-time

1 month ago

DescriptionWho We AreFor more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.Our CultureOur desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard - so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.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.QC Analyst - In-Process Control - Shanbally Cork
Onsite Shift roleExciting opening in a newly 5S certified Analytical lab within QC In-Process team at BioMarin. This is a very diverse role which encompasses all the in-process testing (both analytical and microbial) for the Drug substance and Drug product facilities on site. In addition, the in-process team support testing for all incoming raw materials and testing of the incoming packaging materials for the pack lines.Due to the fast-paced nature of the in-process group the team is a shift based team, operating a 4 cycle.QC In-Process are a high-performing, team-based group, where colleagues are flexible, multi-skilled and empowered to make decisions. QC In-Process operates to an extremely high standard of quality and compliance.A high level of initiative, energy and motivation are key role requirements, as well as organizational skills.Reporting to the QC Team Lead, the primary role of the QC Analyst is to provide support to internal customers by providing quality testing and delivering results in accordance with GMP standards.Other responsibilities include:Perform primary review of QC raw data and trend resultsPrepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agenciesDraft/Update QC SOPsAct as technical resource (SME) and train other analysts in areas of expertiseEvaluate results against defined acceptance criteriaConduct and document laboratory investigations to completionMaintain the laboratory in an inspection-ready stateInteract directly with regulatory agency inspectors during auditsInterface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessaryOther Duties as assigned.Desirable Skills:Excellent communication skills both written and verbalCustomer focus; takes personal responsibility for speed; quality and accuracy of deliverySelf-motivated and ability to work under pressureTeam Leadership - active participation team development and continuous improvement including standard work and 5SSuccessful track record in achieving goals as part of a team within a growing, dynamic environmentDemonstrated adaptability and flexibility to support a growing organizationEducation:BSc in a scientific/engineering discipline with 5+ years (MSc with 3+ years) of relevant (cGMP) laboratory experience.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.

BioMarin

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