Assistant Scientist from Joulé

Warren, NJ 07059

About the Job

Job Title: Assistant Scientist
Location: Warren, NJ
Hours/Schedule: Monday-Friday; Standard Business Hours
Type: Contract

Responsibilities

Ensures the chain of custody of QC samples are maintained throughout the complete life span of samples: receipt, handling, storage, distribution, transfer, and destruction of QC samples at the site.
Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.
Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
Performing sample queries and periodic storage reports, as required.
Responsible for sampling clinical QC incoming materials in collaboration with warehouse personnel and CAR T QC incoming material team.
Initiating and performing investigations, Deviations/CAPAs/Change Controls related to sample management.
Prepares and presents continuous improvement projects to management.
Performs document review related to sample management.
Create and revise SOP, FORM, WP, and TRN related to sample management.
Provide range of support of QC services such as ordering and receipt of lab supplies.
Establish and maintain inventory of QC incoming material, QC material retain, QC samples and QC regulatory retains.
Coordinate and lead trainings for sample management.
Develop understanding and assembly of weekly process schedule assignment for drug product samples and incoming QC materials.
Assist in analytical sample trouble shooting and investigations as needed.
Demonstrate general understanding of root cause analysis and CAPA methodologies.
Maintaining metrics for the sample management group.
Facilitating cold chain transfers of samples, as required.
Assist with preparation and execution of equipment installations related to sample management.
Perform other tasks as assigned.

Requirements

Bachelor’s degree required, preferably in chemistry, microbiology, or related science.
2-3 years of relevant work experience, preferably in a GMP regulated environment.
Experience with cold chain sample storage and transfer.
Experience working in a GMP regulated environment.
Strong communication skills (oral and written).
Proficient with computer software programs/ applications and capable of preparing technical reports as required.
Ability to follow and apply global regulatory and GMP requirements.
Ability to follow, create, revise, and review SOPs.
Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Sample management experience is a PLUS.

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.