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Job Details


Bristol Myers Squibb

Sr. Specialist, Quality Assurance Field Operations (R1559177-en-us)

Operations

Security Operations

Yearly

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.

Summary:


Primary responsibility is to maintain a presence and provide Quality oversight, coaching and support to manufacturing groups. Assists in the identification and generation of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

*Shift: 12 hour rotating (6:00am - 6:00pm)

Responsibilities:

  • Serve as the primary QA contact for multiple manufacturing areas.

  • Performs routine manufacturing batch production record review in support of product release in accordance with specifications and SOPs.

  • Perform walkthroughs of GMP areas documenting observations and areas of concern to support inspection readiness of the manufacturing facility and support areas.

  • Assisting in deviation/nonconformance identification and resolution acting as team member to investigate deviations to determine appropriate root cause and CAPAs or may be responsible for CAPA resolution as required.

  • Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.

  • Assures all electronic and paper documentation, which requires QA review is in compliance with corporate and site procedures, cGMP regulations, and other industry guidelines.

  • Monitors and trends batch record errors, batch record review cycle time to support disposition, and walkthrough observations to provide Quality Assurance management with quality indicator data.

  • Work with operations personnel to resolve issues in a GMP compliant manner.

  • Perform quality tag outs of equipment as required.

  • Support product change over activities.


Qualifications:

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

  • A minimum of 4 years of relevant experience in a regulated environment

  • Experience working directly with assurance of product quality is highly desired

  • Knowledge of biologics manufacturing is highly desirable.

  • Knowledge of US and EU cGMP regulations and guidance.

  • Experience with cGMP documentation review is highly desirable.

BMSBL, BMSBLDMA, VETERAN

#LI-Onsite

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.