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Quality Control Analyst

2 months ago

Warren, United States Net2Source Inc. Full time

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.


Job Title: QC Analyst

Location: Summit, NJ 07091

100% onsite

Duration: 12 months contract

Work Schedule: Mon - Fri, Business Hours


Must Haves:

• 2+ years of relevant analytical testing or QC experience or equivalent combination of education and experience, preferably in a regulated environment.

• 2+ years of experience in cell and molecular biology techniques (e.g., cell-based assays, flow cytometry, qPCR, ELISA, Tissue Culture).

• 2+ years of experience in writing technical documents.

• 3+ years of Microsoft Office


Job Description:

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.


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.


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 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.


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.


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 up to six (6) hours per day.

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