Sr Specialist, QA Method Qualification (R1557117-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 Senior Specialist, QA Method Qualification is responsible for providing QA oversight of analytical method qualification and transfer to support QC testing activities at Cell Therapy manufacturing sites. This work is performed in partnership with Global Product Quality, Analytical Science and QC Laboratory owners/users of qualified methods.
- QA oversight includes but is not limited to review and approval of method validation and transfer plans, qualification protocols, deviations/defects incurred during execution and summary reports.
- The Senior Specialist is responsible for working with cross-functional teams to drive continuous improvement of methods to streamline efficient operations and reduce deviations. This includes:
- 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 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.
- Demonstrated proficiency with health authority requirements and industry guidance on method validation (ICH Q2, etc).
- Demonstrated ability to assess risk, recommend controls and conduct periodic risk review associated with implementation of computerized systems.
- Experience with laboratory information management systems (LIMS) are preferred.
- 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.
EDUCATION AND EXPERIENCE
- Bachelors degree is required, with a preference for Biology, Chemistry, or other scientific fields.
- Ideal candidate will have a minimum of 2 years of directly relevant experience with method validation. Experience in a regulated cGMP environment is required.
WORKING CONDITIONS: OFFICE & cGMP SPACES (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.
- 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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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