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Job Details


Bristol Myers Squibb

Sr. Quality Specialist

Equipment/Technology Specialist

Equipment and Facilities Specialist

No

Syracuse, New York, United States

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.

Bristol-Myers Squibb in Syracuse, NY is searching for an Senior Quality Analyst to join our team. As our Quality Analyst, you will assure the quality of manufactured products complies with all applicable regulations and guidelines through drug substance disposition by coordinating the receipt of deliverables by cross-functional responsible parties.

*This role is a Monday-Friday day shift role

*This position is a hybrid role- 50% onsite.

Duties/Responsibilities:

  • Drives performance within the quality operations team and ensures key quality metrics are met.

  • Quality Lead providing functional area support in identification, reporting and resolution of deviations or non-conformances. Demonstrates independent decision making and leadership.

  • Responsible for ensuring all quality review and support activities are adhere to the highest standards of GMP, EHS and regulatory compliance.

  • Quality Lead supporting Medium and High risk investigation and CAPA teams across all functional areas on site. Leads teams and drives improvement where CAPA resolution is required.

  • Actively works with investigation teams to ensure on-time completion of investigations, CAPA and change controls.

  • Provides direction, coaching, and support to personnel in assigned areas to ensure consistent application of the investigation and CAPA program.

  • Responsible for authorship and revision of quality related procedures.

  • Responsible for quality review and/or approval of Syracuse site procedures and process documentation revisions.

  • Provide quality leadership on project and/or risk assessment teams.

  • Works independently with minimal guidance; Uses knowledge and expertise to develop other team members.

  • Implements and oversees continuous improvement projects within Quality Operations and support areas.

Role Qualifications:

  • Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.

  • A minimum of 4 years direct biologics Manufacturing, Quality Assurance, or Quality Control experience.

  • A minimum of 2 years' experience working with an inventory management system.

  • Knowledge of biologics manufacturing, drug substance disposition, and batch record review.

  • Knowledge and understanding of FDA regulations, in particular the section of cGMPs, as well as Bristol-Myers Squibb policies and procedures.

  • Extensive knowledge of working in a regulated environment and the importance of following procedures, cGMPs and EHS and the skillset to work and manage within a regulated environment.

  • Previous experience in providing sound justification and explanation to representatives from health authorities / regulatory agencies is highly desired.

  • Knowledge of electronic systems including: SAP, LIMS, TrackWise, Infinity, Verity, DCA and Microsoft Office.

  • Ability to work independently and make sound judgments in assuring compliance with regulations under tight timelines.

  • Change agent with demonstrated history of continuous improvement.

BMSBL, VETERAN

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.