QA Senior Specialist Details

QA Senior Specialist

Bristol Myers Squibb - Summit, NJ

Employment Type : Full-Time

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

PURPOSE AND SCOPE OF POSITION:

• The Quality Assurance Incoming Material Disposition Specialist / Senior Specialist is responsible for disposition of incoming materials used in the manufacturing and testing process of CAR-T cell therapy products.
  • These materials include but are not limited to consumables, labelling materials and primary packaging elements, raw materials, and critical reagents.
  • Disposition includes verification that all incoming materials comply with specifications, including visual inspections and/or laboratory testing.
  • The disposition decision for each batch of incoming material is recorded within the inventory management system.

• Additionally, the Senior Specialist is responsible for working with cross-functional teams to drive continuous improvement of incoming materials operations, including:
  • Deviations: understand root causes and identify and implement robust solutions to prevent recurrence of observed deviations.
  • Change Management: assess impact and risk and complete necessary change actions.
  • Policies and Procedures: revise operational procedures to improve compliance and efficiency of operations.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities

• Ability to follow written instructions, provided by Standard Operating Procedures (SOP) and to document results clearly and in a timely manner following performance of tasks.

• Ability to identify and escalate defects for troubleshooting and solution. Successful candidates have strong attention to detail.

• Ability to work as a member of team where combined contribution, collaboration, and time bound results are expected. Successful candidates must be able to provide and receive peer feedback in a positive fashion.

• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.

• Experience is Enterprise Resource Planning (ERP) solutions such as Oracle or SAP are preferred.
• Experience in Quality Management System (QMS) solutions such as Veeva, Trackwise, Documentum are preferred.
  
  • Experience in a laboratory, manufacturing, quality, or warehouse environment desired.

EDUCATION AND EXPERIENCE

• High School diploma or equivalent. Associate’s or Bachelor’s degree or military service is preferred.
• Ideal candidate will have a minimum of 2 years of directly relevant experience. Experience in a regulated cGMP environment is preferred.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.