QC Associate Scientist
Edison-New Brunswick Metro Area, NJ
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.
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.
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.
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.
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.
Education and Experience
Bachelor s degree required, preferable in Science.
3-5 years of relevant work experience, preferable in a regulated environment.
An equivalent combination of education and experience may substitute.