Assistant QC Scientist from Joulé
Warren, NJ 07059
About the Job
Job Title: Assistant QC Scientist
Location: Warren, NJ
Hours/Schedule: Mon - Fri, 8AM - 4:30PM EST
Type: Contract
Join the global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients with serious illnesses.
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.
Requirements
• 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.
• 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.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3
Location: Warren, NJ
Hours/Schedule: Mon - Fri, 8AM - 4:30PM EST
Type: Contract
Join the global biopharmaceutical company committed to discovering, developing and delivering innovative medicines to patients with serious illnesses.
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.
Requirements
• 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.
• 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.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
#M3