Sr. Specialist, Quality Assurance Drug Product Disposition Cell Therapy (R1552745-en-us)
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 Product Disposition Sr. Specialist is responsible for supporting quality and disposition activities at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. The role will aid in the routine and timely release of drug product and assure the quality of manufactured products is in compliance with all applicable regulations and guidelines.
- Functional responsibilities include preparing deliverables for product release within the inventory management system (SAP), ensuring accurate and timely maintenance and review of batch record documentation, providing operations shop floor oversight, and performing document issuance for manufacturing. This individual will also be responsible for reviewing departmental SOP’s and Work Practices.
- REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Knowledge, Skills & Abilities:
- Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
- Experience with cGMP manufacturing, Quality, and/or compliance is desired.
- Previous work experience where attention to detail and personal accountability were critical to success.
- Strong communication skills and the ability to follow written and verbal instructions.
- Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
- Knowledge of electronic systems including any of the following preferred: SAP, Veeva, LIMS/Celabs, Infinity, and electronic batch recording.
- DUTIES AND RESPONSIBILITIES
- Participates in the startup of the Devens Cell Therapy facility, including the development of Standard Operating Procedures, training, and business processes supporting drug product disposition.
- Prepares documentation and deliverables per Standard Operating Procedures required for drug product disposition.
- Verify accuracy and acceptability of drug product documentation, such as Certificate of Analysis or deviation reports, to support drug product lot disposition.
- Perform the review of lot genealogy for all raw materials and components used in each lot to ensure that they are approved and released.
- Works in electronic systems such as SAP, Learning Management, and Document Management systems.
- Coordinates with internal and external stakeholders to troubleshoot issues when required.
- Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations.
- Provides guidance to less experienced staff with atypical events during day-to-day operations.
- Other duties as required.
- EDUCATION AND EXPERIENCE
- B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
- Minimum of 4 years of directly relevant experience in a regulated cGMP environment. Previous quality experience is preferred.
- WORKING CONDITIONS: (US Only)
- Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
- 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 the resources to pursue their goals, both at work and in their personal lives.
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 . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
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