QC Analyst - Quality Control Analytical Testing
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 release of clinical and commercial products. 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.
DUTIES AND RESPONSIBILITIES:
Perform testing of in-process, final product, and stability samples.
- Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
- Anticipate and troubleshoot problems.
- Recommend corrective actions and participate in 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 review of testing data.
- Review all data in accordance with applicable procedures and cGMP requirements.
- Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
- Complete all review in accordance with required release timelines.
- 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.
Support document revision, project, CAPA, and investigation/deviation related tasks.
- Perform assigned tasks within a CAPA, deviation, or project
- Draft and review technical documents, such as SOPs and protocols/reports.
- Communicate effectively with management regarding task completion, roadblocks, and needs.
- Demonstrate initiative, courage, and continuous improvement throughout investigation/corrective action lifecycles.
- Performs other tasks as assigned.
Education and Experience:
- Bachelor’s degree required, preferable in Science.
- 0-3 years of relevant work experience, preferable in a regulated environment.
- An equivalent combination of education and experience may substitute.
Knowledge, Skills, and Abilities:
- Hands on experience with various bioanalytical techniques including ELISA, qPCR and FACS.
- Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
- Technical writing skills.
- Problem solving ability/mentality, technically adept and logical.
- Ability to represent the interests of the group on cross-functional teams.
- Ability to set priorities of the group and manage timelines.
- Ability to work with management locally and globally.
- Ability to communicate effectively with peers, department management and cross- functional peers.
WORKING CONDITIONS (US Only):
- The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
- The incumbent must analyze numerical values on a daily basis.
- The incumbent will be required to work in a laboratory setting for extensive periods of time ranging from 4 to 10 hours per day.
- The incumbent must be flexible to work in a rotating weekend holiday/schedule.
- The incumbent will be working with and around biohazardous materials, including chemical agents.
BMSCART, VETERAN, #LI-Onsite
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.