The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.
An American Company is seeking a QC Sample Management in Princeton, NJ.
Responsible for movement of QC samples and materials in support of sample management in the CAR-T QC laboratories. This includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking and delivery.
• 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 training 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.
Skills & Requirements
• 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 required, preferably in chemistry, microbiology, or related science.
• 1-3 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.
You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.
Additionally, this position is a contract role where Hays offers you the opportunity to enroll in full medical, dental or vision benefits.
Life Insurance ($20,000 benefit)
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Hays is an Equal Opportunity Employer including disability/veteran.
In accordance with applicable federal and state law protecting qualified individuals with known disabilities, Hays U.S. Corporation will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570
Drug testing may be required; please contact a recruiter for more information. #1140927