Newark Metro Area, NJ
The QC Analyst (LAB) is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products by performing laboratory compliance duties.
Ability to accurately and completely understand, follow, interpret and apply cGMP requirements Global Regulatory in a laboratory setting
Hands on experience with various bioanalytical techniques including Flow Cytometry.
Technical writing skills
Duties and Responsibilities
Perform laboratory compliance tasks to ensure the laboratories are audit ready, at all times
Preparing critical reagents
SOP creation and revision
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.
Support document revision, project, CAPA, and investigation/deviation related tasks.
Perform assigned tasks within a CAPA, deviation, or project
Draft technical documents, such as SOPs and protocols/reports.
4. Education and Experience
Bachelor s degree required, preferable in Science.
0-3 years of relevant work experience, preferable in a regulated environment.