ASSOCIATE SCIENTIST - QC SAMPLE MANAGEMENT - TSR Consulting : Job Details

About TSR: TSR is a relationship-based, customer-focused IT and technical services staffing company. For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients. Mission & Vision We do not believe in building a vision around the company but building a company around our vision, which is simply; Every employee's voice matters, their effort is appreciated, and their talent is rewarded. We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner. Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.ASSOCIATE SCIENTIST - QC SAMPLE MANAGEMENTJob Description

• Location: Warren, New Jersey
• Type: Contract
• Job #81418

Our client, a leading pharmaceutical company, is hiring an Associate Scientist, on a contract basis. Job ID #: 81418 Work Location: Warren, NJ - 100% on site 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, and shipments within the cGMP operation for CTDO Developmental QC for CAR T. Education/Experience:

• Bachelors degree required, preferably in chemistry, microbiology, or related science.
• 2 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.

Knowledge/Skills:

• 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 of time with minimal supervision.
• Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.

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.