QC Associate III

Location
Bothell, WA, United States
Posted
Sep 23, 2020
Ref
R1522334
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

The Analyst will support the Laboratory Information Management System used by the Quality Control group at the Juno Manufacturing Plant. The selected candidate will be responsible for maintaining, updating and troubleshooting all LIMS related issues. Additionally, they will assist with related projects such as system updates and/or enhancements. Customer service and patient focus is a must as everything must be delivered swiftly, efficiently and within regulatory guidelines and compliance. Knowledge of GxP Regulations and how they apply to complex lab workflows is recommended.

Key Responsibilities:
• Collaborate with QC and IT to develop new functionality and expand existing functionality in LIMS as required by evolving business requirements.
• Collaborate with IT and Computer System Validation Departments to facilitate completion of computer system validation activities.
• Provide site specific LIMS application support, problem reporting and resolution.
• Assist JuMP QC to develop and maintain Standard Operating Procedures, user guides, and other relevant documentation.
• Ensure ongoing LIMS proficiency and provide training to Quality and JuMP personnel.
• Collaborate with IT to ensure adequate infrastructure support to LIMS.
• Assist with change control impact assessments
• Participate in internal audit reviews of the system and system documentation

Basic Qualifications:
• BS in a science or computer science discipline.
• 3+ years experience in QC Role with LIMS system experience.
• Knowledge of CGMP/ICH/FDA regulations with 21 CFR Part11
• Working knowledge of QC laboratory operations.
• Working understanding of change control and software validation
• Strong troubleshooting ability
• Must be able to interact and communicate effectively with other departments to meet project milestones and goals.

Preferred Qualifications:
• 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.

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.