Sr. Specialist, Quality Assurance Technical Operations
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.
Sr. Specialist, Quality Assurance Technical Operations
Provide Quality support for Quality Control laboratories, Validation, and Quality Controls projects. Assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. Support through review and approval of investigations, change control records, and technical protocols. May assist in preparing for of regulatory and customer audits.
Quality support of Quality Control laboratories, Technical Services programs, and equipment maintenance activities.
Reviews and approves change controls, exception reporting, investigations and corrections and actions associated with all areas of the manufacturing process including QC activity related to, incoming materials, manufacturing , facility, and utility systems.
Review and approves validation/qualification protocols and reports associated with new products, analytical methods, equipment, and materials.
Participates in ongoing laboratory operations/continuous improvement and risk management projects
Identifies and reports discrepancies from normal practices or procedures to management.
Makes sound decisions by exercising judgment within generally defined practices and policies and applies appropriate notification to management as appropriate.
Participates as requested in the response team for audits and inspections by world health authorities
Represents QA in cross functional meetings.
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 with at least 3-4 years focused on product quality.
Previous GMP Quality Control laboratory knowledge and/or experience in biotech bulk and finished product manufacturing is highly desirable.
Knowledge of US and EU cGMP regulations and guidance.
Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity (Veeva Vault), LES, DocMan and Maximo desirable.
Experience working in a team-based environment with a diverse group of people.
Excellent writing and oral communication skills are required.
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.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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