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Job Details


Bristol Myers Squibb

Quality Control Associate II

Technology

Quality Assurance

Yearly

No

Bothell, Washington, United States

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.

PURPOSE AND SCOPE OF POSITION:

The primary focus of the Quality Control Associate II role will be to support flow cytometry testing and other tasks for viral vector lot release within a cGMP environment. Additionally, this role may support raw material visual inspection, gas sampling and testing, raw material Certificate of Analysis generation, and material specification review.

M-F full-time 40 hrs/week (day shift)

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

Education:

  • BS in a scientific discipline.

Experience

  • 3+ years of QC testing within a regulated environment, or equivalent combination of education and experience.
  • Experience working in a regulated (GxP) environment and familiarity with various Quality Systems, preferred.
  • Demonstrated success working in a high-performing, business results-driven environment.

Knowledge, Skills, and Abilities

  • Flow cytometry experience is strongly preferred
  • Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects with little supervision.
  • Strong analytical and communication skills.
  • Computer proficiency as well as strong scientific and organizational skills.
  • Experience working in a GMP environment.
  • Demonstrated success working in a high-performing, business results-driven environment.
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
  • Ability to maintain flexible intellect and adjust to a dynamic work environment.

DUTIES AND RESPONSIBILITIES:

Key Responsibilities

  • Perform or support cGMP flow cytometry testing and review
  • Ensure timely completion of testing and tasks as assigned.
  • Perform assay and form review.
  • Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports.
  • Participate in cross-functional training.
  • Revise test methods, SOPs, raw material specification, and/or sample plans as appropriate.
  • Identify and facilitate continuous improvements.
  • Participate in technical transfer and validation protocols for QC assays.
  • Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.
  • Assist in the implementation of new assay methodologies and the associated instrumentation.
  • Onboard new materials and reagents.
  • Identify and support initiation and completion of Deviations, CAPAs and Laboratory Investigations.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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 have ability to work assigned shift (Day, Night, Weekends and/or holidays).
  • 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.
  • Require to work in and around laboratories and controlled, enclosed, restricted areas, included clean rooms.
  • Require to carry and/or lift up to 10 pounds several times a day.

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.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.