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.
The Quality Assurance Shift Supervisor is responsible for leading a team that provides Quality oversight of GMP operations including batch record review and associated cGMP records to assure product quality is consistent with established standards and in compliance with regulatory and industry standards. The Quality Assurance Operations team supports both clinical and commercial autologous cell therapy manufacturing at the Bothell, WA manufacturing site. This is a Sun-Wed 1:00pm-12:00am shift.
Primary DUTIES AND RESPONSIBILITIES:
- Promotes a safe work environment
- Develops and manages a daily plan for the Quality Assurance Operations shift, responsible for review and approval of documents/records, including executed batch records, standard operating procedures, material specifications, and validation protocols and reports.
- Supports end to end deviation management process.
- Ensures the safety of the patients by adhering to company policies and procedures, and cGMP requirements.
- May participate in cross functional project teams as a Quality representative.
- Responsible for people management lifecycle including recruitment, development and performance management.
- Identifies and mitigates risks in production, quality and supporting operations that could negatively impact the safety, identity, strength purity or quality of the product.
- Assists in the design, implementation and continuous improvement of Quality Systems.
- Actively pursues learning of required skills and new skills.
- Ensures team goals, site and corporate objectives are met.
Knowledge, Skills, and Abilities:
- Knowledge in electronic batch documentation systems is preferred,
- Experience in deviation management systems and causal analysis tools desired.
- Experience in aseptic processing and cleanroom environments is preferred.
- Must exercise sound judgment and be able to critically evaluate available information to identify appropriate course of action in a timely manner.
- Proven commitment to quality and continuous improvement.
- People management experience required.
- Master'sdegree in related field is preferred. Minimum ofBachelor'sdegree and/or equivalent combination of education and experience is required.
- 7-10 years of relevant cGMP experience in FDA/EMA regulated environment
- Experience in cellular therapy field is preferred.
WORKING CONDITIONS(US Only):
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.
- Work in areas that may have strong magnets.
- May work in areas with exposure to vapor phase liquid nitrogen
- Must be able to obtain gowning qualification to enter a cleanroom environment
- May be required to work nights, weekends and holidays in a 10-hour shift structure.
- Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.
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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