Senior Specialist, QA Disposition position at Bristol Myers Squibb.| Netherlands

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Bristol Myers Squibb Senior Specialist, QA Disposition

Experience: Highly Experienced

Pattern: full-time

Country:

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Associate

Leiden – NL....Netherlands

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us . Bristol Myers Squibb Netherlands Bristol Myers Squibb has been active in the Dutch market for over 50 years, employing people across a range of activities and business units in Utrecht, The Netherlands. The Netherlands is also home to our first European Cell Therapy facility, located at the Leiden Bio Science Park, the largest life sciences cluster of The Netherlands. This new state of the art facility is focused on commercial manufacturing with capabilities for multi-product Cell Therapy manufacturing. You can become part of this exciting journey. Check out this video if you want to know more about it! The Netherlands has everything it takes to become the medicines hub of Europe, the so-called Boston by the North Sea. As we continue to expand our footprint by building this new site, we are looking to grow our team. Would you like to become an important chain in our worldwide network to bring this new personalized treatment to patients suffering from blood cancer? Join us and be a game changer! For more information about Bristol Myers Squibb Netherlands, visit us at bms.com/nl or careers.bms.com/nl Position Summary The Senior Specialist, QA Disposition is responsible for quality and disposition activities at the Cell Therapy Facility (CTF) in Leiden, The Netherlands, in accordance with Bristol Myers Squibb (BMS) policies, standards, procedures and Global current Good Manufacturing Practice (cGMP). Functional responsibilities include performing operational and timely preparation for deliverables for incoming materials, intermediate and drug product disposition within the inventory management system (SAP). This includes but is not limited to review and/or approval of all disposition inputs associated to materials, intermediate and drug product prior to release and provides input in the development systems impacting disposition i.e. Manufacturing Execution Systems (MES) and CeLabs LIMS System. Duties/Responsibilities Prepares intermediate, drug product and incoming materials disposition documentation and deliverables per SOPs. Reviews or inspects for accuracy and acceptability of the disposition inputs and deliverables to support disposition of materials and batches, including: certificate of analysis, deviations, lot genealogy, specifications, and standards. Performs disposition of materials and intermediate products Collaborates with stakeholders on non-conforming materials or batch deviation investigations, reporting, and corrective and preventative actions (CAPA). Works on assignments of moderate to high complexity where judgment is required in resolving problems and making routine recommendations. Develops, maintains, or reviews SOPs, material specifications, training, and business processes supporting disposition. Coordinates with internal and external stakeholders to troubleshoot concerns and issues as required. Participates in Master Data management and supports master data for incoming materials. Provides guidance to less experienced staff with atypical events during day-to-day operations. May own Quality System records such as deviations, CAPAs, or Change Controls. Supports continuous improvement projects to improve efficiency of the dispositioning and related business processes. Supports the Disposition group at various project meetings and anticipate lot disposition impact. Provides support as SME for change controls, deviations, project teams and provide quality input in the resolution of disposition related issues. Supports internal and external inspections as required. Maintains compliance with assigned learning plan. Supports integration of newer team members. Leads meetings and represents function at cross functional meetings. Shares data/ knowledge within and across team. Builds & maintains strong relationships with partner functions. Advanced knowledge and experience with cGMP manufacturing, quality, and compliance to make appropriate decisions as needed. Ensures product quality and compliance by enforcing quality assurance policies and procedures; ensures the required processes, procedures, and resources are adhered to while performing responsibilities. Work is self-directed and requires minimal direction to complete tasks by following work practices, lists, forms, and/or procedures. Reporting Relationship: Senior Specialist Quality Assurance Disposition reports into Director, Disposition Operations. Qualifications: Ability to research, understand, interpret, and apply internal policies and regulatory guidelines. Ability to interpret data and results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation. Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy. Ability to work in a fast-paced team environment and changing priorities. Detail oriented and task focused with ability to meet deadlines and prioritize work. Able to work across functional groups and teams to ensure requirements are met. Self-motivated and contribute to a positive team environment. Curious and ability to think critically to create innovative solutions. Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Confident in making decisions for routine and non-routine issues. Routinely, recognizes Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Develops procedures. Good social skills. Ability to cooperate and adapt to changing circumstances. Knowledge of electronic systems including any of the following preferred: Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP), SAP, and Quality Management systems . Education/Experience/Licenses/Certifications: Bachelor's degree in engineering, a life or physical science related field (including biology, biochemistry, chemistry) is preferred. High school diploma/ Associate’s degree with equivalent combination of education and work experience is acceptable. 4+ years of directly relevant experience in a regulated cGMP environment. Previous quality experience is strongly preferred. #LI-Onsite Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS. If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection . Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1599128 : Senior Specialist, QA Disposition

Senior Specialist, QA Disposition job opportunity at Bristol Myers Squibb.

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