Sr. Specialist, QA Manufacturing Operations Lead (R1555400-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.
Bristol-Myers Squibb in Devens, MA, is seeking a remarkable, Quality Assurance Manufacturing Operations Lead to join our Quality team.
As our Quality Assurance Manufacturing Operations Lead, you will provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. You will also perform review and approval of documentation associated with in-process materials, and manufactured product. This role will also assist in the identification, generation and quality review of investigation records that may result during day-to-day operations. You will also assure the quality of manufactured products complies with all applicable regulations and guidelines.
This role works on a 12-hour rotating day shift 36/48 which involves holidays that fall on the schedule. Required to work every other rotating weekend, some holidays, and during adverse weather conditions in support of the manufacturing facility. Flexibility at beginning and end of shift may be required.
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.
Supports return to service walkthroughs and Manufacturing inspection readiness walkthroughs per procedures as needed.
Assures all electronic and paper documentation, which requires QA review follows corporate and site procedures, cGMP regulations, and other industry guidelines.
Reviews, approves and provides guidance for quality master data Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing related SOPs.
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.
Assist Operations by providing quality oversight and guidance for atypical events.
May provide guidance to less experienced staff. May support the Quality approval of Master Batch Records. Supports the Quality review and closure manufacturing deviations.
May support release of incoming or manufactured products. Other duties as assigned.
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or and equivalent of education and job experience
A minimum of 3 years of relevant experience in a regulated environment with 2 years focused on product quality preferred
Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance.
Knowledge of electronic batch record systems, DeltaV, and other electronic systems applicable to laboratory test result generation, inventory management, investigations and equipment tracking, and maintenance is desirable.
BMSBL, BMSBLDMA, 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 firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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