QC Analyst in Summit, NJ

100% onsite

Bachelor's degree required

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

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.

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.

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