ASSOCIATE SCIENTIST – QC SAMPLE MANAGEMENT
Duration : 6 Months
Schedule : Monday-Friday; Standard Business Hours
Work Location : 100% Onsite Position
Position Summary
The Assistant Scientist, Clinical QC Sample Management position is responsible for the movement and control of Quality Control (QC) samples and materials in support of the QC laboratories at the CAR T manufacturing facility in Warren, NJ.
This primarily includes, but is not limited to :
- Sample collection and distribution
- Inventory control
- Chain of custody
- Sample tracking
- Documentation
- Shipments within the cGMP operation for CTDO Developmental QC for CAR T
Required Competencies : Knowledge, Skills, and Abilities
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 work in a collaborative team environment.Ability to work independently for extended periods with minimal supervision.Ability to adapt and adjust to changing priorities and manage multiple assignments with challenging / conflicting deadlines.Duties and Responsibilities
Ensures the chain of custody of QC samples is maintained throughout their complete life span : receipt, handling, storage, distribution, transfer, and destruction of QC samples at the site.Maintains sample tracking and chain of custody records in accordance with GMP requirements and written procedures.Ensures that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.Performs sample queries and periodic storage reports, as required.Responsible for sampling clinical QC incoming materials in collaboration with warehouse personnel and the CAR T QC incoming material team.Initiates and performs investigations, Deviations / CAPAs / Change Controls related to sample management.Prepares and presents continuous improvement projects to management.Performs document reviews related to sample management.Creates and revises SOPs, FORMs, WPs, and TRNs related to sample management.Provides a range of support for QC services such as ordering and receipt of lab supplies.Establishes and maintains an inventory of QC incoming material, QC material retain, QC samples, and QC regulatory retains.Coordinates and leads trainings for sample management.Develops an understanding and assembly of the weekly process schedule assignment for drug product samples and incoming QC materials.Assists in analytical sample troubleshooting and investigations as needed.Demonstrates a general understanding of root cause analysis and CAPA methodologies.Maintains metrics for the sample management group.Facilitates cold chain transfers of samples, as required.Assists with preparation and execution of equipment installations related to sample management.Performs other tasks as assigned.Education and Experience
Bachelor’s degree required, preferably in chemistry, microbiology, or related science.2-3 years of relevant work experience, preferably in a GMP-regulated environment.An equivalent combination of education and experience may substitute.Sample management experience is a PLUS.Note :
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.
