Bristol Myers Squibb Company

QC Analyst

Location
Celgene, NJ, United States
Posted
Sep 10, 2020
Ref
R1527224
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.

The QC Analyst is responsible for supporting Quality Control Bioanalytical testing for the release of all clinical and commercial products associated with CAR T Cell Therapy Development & Operations (CTDO). This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.

REQUIRED COMPETENCIES:

Knowledge, Skills, and Abilities:

Education B.S. in Analytical Chemistry or Biochemistry or Biology related field Experience

Hands-on experience with various bioanalytical techniques including but not limited to flow cytometry, qPCR, ELISA, Viable Cell Count.

Ability to accurately and completely understand, follow interpret and apply Global Regulatory an cGMP requirements.

Technical writing skills.

Problem solving ability/mentality, technically adept and logical.

Ability to set priorities of the group and manage timelines.

Ability to communicate effectively with peers, department management and cross-functional peers.

Perform testing of in-process, final product, and stability samples.

 Utilize scientific principlesto assist in analytical testing methods and the proper use of laboratory equipment.

 Anticipate and troubleshoot problems

 Recommend corrective actions and participate in the development of best practices.

 Understanding of regulatory guidelines and can independently develop, write and execute methods, protocols, reports and other related documents.

 Complete all work in a timely manner.

 Work and communicate effectively within the team to ensure timelines are met. Perform peer verification of testing information.

 Verify all testing information in accordance with applicable procedures and cGMP requirements.

 Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

 Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required. Train new analysts to general job duties.

 Complete necessary training to become a qualified trainer.

 Perform training effectively.

 Document training per procedural and cGMP requirements.

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.