Assistant QC Scientist

Job Title : Assistant QC Scientist

Duration : 12 Month Contract (Possible extension based on work performance)

Location : Warren NJ

Onsite Position

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

Job Description :

Manage Would Like to See Candidate's with :

• 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

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.

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 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.

Additional Information :

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

Additional Job Requirements :

Lab w / o blood & animal

Position Handles Hazardous Materials