Job ID: 59497-1

Position: Quality Control Technician

Location: Summit, NJ 07901

Duration: 12 months

100% on-site

The QC Analyst is responsible for supporting Quality Control bioanalytical testing for the 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.

Education:

A bachelor’s degree is 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.

Experience:

• 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 for 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.

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 reviews 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 the 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.

WORKING CONDITIONS (US Only):

• 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 for up to six (6) hours per day.

• The incumbent will be working around biohazardous materials, including chemical agents, for up to six (6) hours per day.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.