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Specialist, QA Operations Shopfloor

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locations

Leiden – NL

time type

Full time

posted on

Posted 3 Days Ago

job requisition id

R1582701

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 rich in diversity. 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

. Position Summary The

Specialist , QA Shopfloor Operations is responsible for quality activities

at the CTF in Leiden,

in accordance with Bristol Myers Squibb policies, standards, procedures, and global current Good Manufacturing Practice (cGMP). Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues. Duties/Responsibilities Perform QA shopfloor activities. Ensure manufacturing compliance with applicable procedures and batch records. Perform real time review of manufacturing batch records. Review manufacturing shop floor documentation. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles. Must be skilled in planning and organizing, decision-making, and building relationships. Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management. Reporting Relationship Specialist, QA Operations Shopfloor reports into Manager, QA Operations Shopfloor. Qualifications Specific Knowledge, Skills, Abilities: Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. Understands continuous improvement and improves efficiency and productivity within the group or project. Builds relationships internally within and with cross functional teams. Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes. Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies. Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. Able to recognize conflict and notify management with proposed recommendations for resolution. Must possess an independent mindset. Work is self-directed. Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Confident in making decisions for non-routine issues. Develops and revises procedures. Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Able to prepare written communications and communicate problems to management with clarity and accuracy. Able to effectively multi-task. Knowledge of global cGMP requirements. 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. 2+ years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. 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 an inclusive culture, promoting diversity 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 a diverse 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. 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. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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