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

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.