What are the responsibilities and job description for the Assistant Scientist position at System One?
Job Title: Assistant Scientist
Location: Warren, NJ
Hours/Schedule: Monday-Friday; Standard Business Hours
Type: Contract
Responsibilities
Requirements
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.
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.
