Quality Control Technician
: Job Details :

Job Title: Quality Control Technician

Location: Summit, NJ

Duration: 12 Months+

Summary:

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 the 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:

· Bachelor's degree required, preferably in Science.

· 2-4 years of relevant work experience, preferably in a regulated environment.

· An equivalent combination of education and experience may substitute.