QA Associate

Profile

Who We Are For 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 Culture Our 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 u2013 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. BioMarinu2019s 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 BioMarinu2019s 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 patientsu2019 lives. BioMarin is a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.QA Associate - Fill Finish - Shanbally, Corku00A0As part of establishing sterile filling operations at the Shanbally facility, this role (which reports to the QA Operations Manager) will provide QA support for the start-up of the facility, before moving into routine QA support of same. The successful candidate will also have proven capability in promoting Quality across cross-functional teams, to deliver on-time high quality processes and products, whilst ensuring continuous process improvement.u00A0Key Responsibilities: Provide Quality direction and oversight of the start-up, technical transfer, operation, and continuous improvement of Sterile Drug Product Filling operations. Provide Quality input to Change Controls, Protocols and Reports ensuring scope of records are clear and implementation activities are robust and timely. Write, review and approve Standard Operating Procedures, Work Instructions, Quality Technical Agreements, Master Batch Records, Specifications and other GMP documentation in accordance with BioMarin Policies.u00A0 Participates within inter-departmental and cross-functional project teams to immediately address issues and questions in real time to help ensure project timelines are achieved. Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements. Provide Quality input and guidance to ensure Lot Release (Components/Raw Materials/Drug Product) of high quality products in compliance with current Good Manufacturing Practices (GMPs). Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs. Provide Quality input to Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable. Exercise judgment to determine appropriate action, ensuring proper escalation when issues are identified as per applicable procedures for compliance, escalation and corrections. Pro-actively identifies compliance risks and takes appropriate preventative actions. Proactively identify potential issues, lead root cause analysis, make recommendations and aid in implementation for more complex and non-reoccurring issues. Ensure high level of Quality / cGMP Awareness in the Project Team and Sterile Filling Team. Lead Area GMP Certification Activities. Support pre-approval Regulatory Inspection readiness to ensure regulatory approvals are obtained. Support all Quality Assurance elements needed to facilitate new product launches.u00A0u00A0QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTSREQUIRED: Degree or 3rd level qualification (Science, Quality). QP Qualification would be an advantage. Demonstrated experience in Sterile Drug Product Filling and start-up of same. Relevant experience (5yrs ) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role. Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels. Strong organizational skills, including ability to follow assignments through to completion. Proficiency in PC skills such as Excel, Word, PowerPoint. Proven decision making capability with full accountability and responsibility. Demonstrated coaching skills. Excellent written and verbal communication skills. Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations.DESIRED:u00A0 Experience in Sterile Drug Product Filling and start-up of same. Evidence of Continuous Professional Development. Evidence of Validation knowledge/experience. MES experience. Good knowledge of Lean / Continuous Improvement practices and root cause analysis.BEHAVIOURS: Always focused on the patient and customer needs. Resilient profile with the ability to deliver in a challenging environment. Ability to engage and manage multiple stakeholders to achieve the objective. Curious with learning agility. Operationally excellent, with attention to detail. Organised with systematic approach to prioritisation. Process orientated to achieve the business objective.u00A0 u00A0 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.u00A0u00A0u00A0u00A0u00A0

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