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Quality Control Analyst

5 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: Assistant QC Scientist

Location: Warren, NJ 07059

100% onsite

Duration: 12 months contract

Work Schedule: Mon - Fri, 8AM - 4:30PM EST


Must Haves:

2+ years of hands-on experience with bioanalytical technique such as ELISA, Potency, Cell based assays, etc.

1+ Experience working in regulated environment (e.g. cGMP, cGLP)

Previous Assay Transfer, assay validation experience

Previous CAR-T experience preferred

Technical understanding and troubleshooting skills

Experience/knowledge in deviation, CAPA, Change Control

Team player, flexible, good communication skills


Job description:

Purpose:

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.


Required Competencies: Knowledge, Skills, and Abilities

• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based assays.

• Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality Control group.

• 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, stability samples, and method transfer.

• 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.

• Complete all work in a timely manner.

• Work and communicate effectively within the team to ensure timelines are met.

• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.

• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.

• Document training per procedural and cGMP requirements.

• Perform assigned tasks within a CAPA, deviation, or project

• Draft and review technical documents, such as SOPs and forms.

• Communicate effectively with management regarding task completion, roadblocks, and needs.

• Performs other tasks as assigned.


Education and Experience

• Bachelor’s degree required, preferably in Science.

• 2-3 years of relevant work experience, preferably in a regulated environment.

• An equivalent combination of education and experience may substitute. EX: if the person has a Master degree but less exp. (1-2 years), manager would still consider that candidate.