QC Associate III Cell Biology

  • Anywhere

Company :
Bristol-Myers Squibb

Location :
Bothell, Washington

Expiry Date :
Sat, 05 Dec 2020 23:59:59 GMT

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Description :
At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through 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. This is a Sun – Wed PM Shift 1:30p-midnight PURPOSE AND SCOPE OF POSITION: The primary focus of the Quality Control Associate III role will be to support product lot release and in-process testing within a cGMP environment. Additionally, this role will provide technical support and troubleshooting for the support of lot release, in-process, and stability testing. REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities: Education: – BS in a scientific discipline. Experience – 6+ years of analytical QC testing within a regulated environment, – Experience working in a regulated (GxP) environment and familiarity with various Quality Systems preferred. – Cell based assays, ELISA – Demonstrated success working in a high-performing, business results-driven environment. Knowledge, Skills, and Abilities – Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects without 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. – Detail-oriented with strong time-management skills. DUTIES AND RESPONSIBILITIES: Key Responsibilities – Perform or support cGMP lot release, in-process, and stability testing using various software packages. – Ensure timely completion of testing and tasks as assigned. – Perform assay and form review. – Lead assay transfer and method validation of by representing site QC in cross-site validation protocols and providing data to support final reports. – Participate in cross-functional training. – Author and revise test methods, SOPs, raw material specification, and/or sample plans as appropriate. – Identify and facilitate continuous improvements. – Execute 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. – Identify and support initiation and completion of Deviations, CAPAs and Laboratory Investigations. – Act as a lead in small to medium scale projects. – Act as owners for Deviation, CAPA, Laboratory Investigations, and Change Controls records. – Train other on QC processes and procedures 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. BMSCART 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.