Job Details
Specialist, Quality Assurance Operations ( 11A-7P)
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 looking for an experienced QA Operations Floor Support Specialist to join our amazing biologics team. As our QA Operations Floor Support Specialist, you will provide Quality Assurance assistance and oversight during start up of clinical manufacturing facility and manufacturing of clinical/commercial drug substance.
You will also perform review and approval of records for the manufacture of in-process materials, drug substance and other GMP processes as required. This role will assist in the identification, generation and review of investigation records that may result during day-to-day operations. This is a meaningful role that will assure the quality of manufactured products complies with all applicable regulations and guidelines.
This role works on-site, Monday - Friday 11 a.m. - 7 p.m.
Role Responsibilities:
This role will primarily support the Devens Single Use drug substance manufacturing facility. At the Single Use Facility (SUF), we produce clinical and commercial drug substance and cell banks to support BMS’s product pipeline using innovative disposable technology. The Field Quality Operations Analyst will provide support on-the-floor (IN-SUITE) for daily manufacturing operations in the Single Use Facility.
Assures all electronic and paper documentation, which requires QA review is in compliance with corporate as well as site procedures, regulations, and other industry guidelines.
Performs manufacturing batch production record review in support of product release in accordance with specifications and SOPs.
Performs walkthroughs of the manufacturing facility and applicable support areas documenting observations and points of concern.
Supports return to service walkthroughs and other walkthroughs per procedures as needed.
Authors and revises Quality specific SOPs and may provide Quality review and approval of manufacturing and support area related SOPs.
Monitors and trends batch record error and right-first-time batch record review cycle times.
Supports disposition and provides Quality Assurance management with quality indicator data. Supports the Quality review and closure of low risk investigations.
Participates in the creation of a team based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals.
Demonstrates appropriate examples of compliance behaviors and attitudes. Supports on the floor activities in collaboration with Manufacturing and additional support groups as needed.
Other duties as assigned.
Role Requirements:
Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
Prior GMP Compliance experience preferred.
Knowledge of biotech bulk manufacturing, disposable technologies and analytical testing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance for clinical and commercial phase products is preferred.
Knowledge of electronic and paper 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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