Assistant Quality Control Scientist

Job Description

Job Summary:

• The Assistant QC Scientist is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products.
• his 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, 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.

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.

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.

Working Conditions:

• The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is required.
• The incumbent must analyses 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.

Additional Job Requirements:

• Lab w/o blood & animal.
• Position Handles Hazardous Materials.