Qlty Assurance Methods
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.
1. Purpose and Scope of Position
The QC Associate Scientist 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.
2. Required Competencies: 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.
3. 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.
4. Education and Experience
- Bachelor’s degree required, preferable in Science.
- 3-5 years of relevant work experience, preferable in a regulated environment.
5. Working Conditions
- 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 working a laboratory setting up to six (6) hours per day.
- The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.
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 the resources to pursue their goals, both at work and in their personal lives.