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 Summit, NJ is searching for a remarkable Scientist, QC Compliance Microbiology to join our growing team! The Scientist, QC Compliance Microbiology will work both independently and with the team overseeing all of the QC microbiology related compliance records across Deviations, CAPA's and Change Control. As our Scientist, you will be primarily responsible for providing technical assessments in relation to product impact, disposition assessments, root cause analysis, and hypothesis driven investigational testing plans. In addition, you will work closely with the Lab Excellence team on areas for improvements. This position is part of the Summit Quality Control Compliance Team, which is comprised of two pillars: Compliance and Continuous Improvement. While this is a site-based role, collaboration across other sites in the CTDO network and the BMS Global network is essential.
*This role works Sunday - Wednesday - Saturday, Second Shift*Role Responsibilities:
- Identify opportunities for operational improvement in the Quality Control department for Deviations, Corrective and Preventative Actions and Change Control relative to CTDO and Summit - S12 goals.
- Responds to challenges and additional workload in a professional and objective manner.
- Ability to multitask, prioritize workload, document properly and interpret data accurately.
- Collaborate with other Site and network Operational Excellence team members to ensure initiatives external to the S12 site can be leveraged to obtain intended benefit of those external initiatives.
- Excellent writing and presenting skills.
- Develop and implement standard operating procedures, work practices and guidance.
- Carry out responsibilities in accordance with the organizations policies, procedures, and state, federal and local laws.
- Ensure compliance with current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements at all times.
- Follow directions properly, work cooperatively as an individual contributor and as a team member.
- Communicate effectively with QC peers, cross-functional peers and management.
- Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports as needed.
- Support investigations and CAPAs associated with QC Department.
- Support data trending and tracking of results and draw conclusions from said data.
- Take ownerships/accountability of assigned tasks and come up with solutions/improvement suggestions.
- Bachelors degree in Microbiology, Molecular Biology, or related discipline. An equivalent combination of education and experience will be considered.
- Minimum 3 years of experience working in a regulated manufacturing environment.
- Must have strong microbiological technical skills to provide assessments in relation to product impact, disposition assessments, root cause analysis, and hypothesis driven investigational testing plans.
- Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must be able to routinely recognize quality issues and interpret problems, as well as propose solutions for complex issues.
- Must understand continuous improvement and be able improve the compliance and efficiency of the quality system.
- Must be able to effectively prepare and convey data analysis to management and others within the group with clarity and accuracy.
- Must be self-directed, complete routine tasks independently and be confident in making decisions in respective subject matter area, consulting with management for decisions outside of established processes.
- Comfortable providing input/guidance to others within the department and across the organization in deviations technical writing.
- Knowledge of problem-solving methods used to perform Root Cause Analysis.
- Propose solutions for issues and work with management to resolve.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to support internal and health authority inspections of facility.
- Equipment Usage During Work Period: Computer 70%; Phone and Electronic Devices 30%.
- Sitting at a computer terminal for an extended period.
- Requirement to work in a conference room / meeting environment for moderate periods of time.
- Occasional periods in labs or production area, requiring some level of gowning.
- Light to moderate lifting.
- Regular, predictable attendance is required, plus flexibility with schedule (weekends, holidays, extended hours) as business demands dictate.
- Moderate noise i.e., business office with computers, phone, and printers.
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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