What are the responsibilities and job description for the Associate Scientist - QC Sample Management position at ECLARO?
Associate Scientist - QC Sample ManagementJob Number : 25-03496Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an Associate Scientist - QC Sample Management for our client in Warren, NJ.ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!Position Overview : 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. 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. Position handles hazardous materials.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.Required Qualifications : 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. Bachelor’s Degree, 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.If hired, you will enjoy the following ECLARO Benefits : 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLAROIf interested, you may contact : June Binuyajunethel.binuya@eclaro.com212-804-7476June Binuya | LinkedInEqual Opportunity Employer : ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
