Quality Control Analysts
Skills
Job description for Quality Control Analysts at Bristol Myers Squibb
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.
REQUIRED COMPETENCIES:
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:
- 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.
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