Associate I-III, Quality Control

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 QC Associate role is responsible for supporting the release, stability, and in-process testing of Cell Therapy clinical and commercial products within the Quality Control department. Additionally, the QC Associate may assist with investigations and continuous improvement efforts.

Education:

Bachelor's degree or equivalent combination of education and experience

Experience:

0 to 3+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in regulated environment.

Knowledge, Skills, and Abilities

• Demonstrated experience with basic laboratory techniques and laboratory safety practices.
• Experience in cell, molecular biology, and or microbiology techniques such as cell-based assays, flow cytometry, qPCR, ELISA, endotoxin and/or aseptic technique is preferred.
• Knowledge of regulatory standards as they apply to GMP laboratories is preferred.
• Experience with LIMS and ELN computer applications is preferred.
• Attention to detail and demonstrated organizational skills.
• Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects.
• Advance technical writing skills and ability to effectively communicate with peers and department management.

Key Responsibilities

• Perform testing and data review of in-process, final product, and stability samples of cell therapy product in accordance with applicable procedures and cGMP requirements.
• Ensure timely completion of testing and tasks as assigned.
• May train on additional test methods and provide support to a broader spectrum of testing responsibilities.
• Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports.
• May participate in projects and continuous improvements efforts.
• 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.
• Identify and support initiation of Deviations, CAPAs and Laboratory Investigations through data gathering and interview process.
• Communicate effectively with management regarding task completion, roadblocks, and needs.

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:

• 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.