Demo

QC Sample Management Assistant Scientist

Cynet Systems
Warren, NJ Full Time
POSTED ON 2/12/2025
AVAILABLE BEFORE 4/28/2025

Job Description :

Pay Range : $28hr - $32hr

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.
  • ssist 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.
  • ssist with preparation and execution of equipment installations related to sample management.
  • Perform 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.
  • n equivalent combination of education and experience may substitute.
  • Sample management experience is a PLUS.
  • 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.
  • Position Handles Hazardous Materials
  • 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.
  • bility to follow and apply global regulatory and GMP requirements.
  • bility to follow, create, revise, and review SOPs.
  • bility to work in a collaborative team environment.
  • bility to work independently for extended periods of time with minimal supervision.
  • bility to adapt and adjust to changing priorities and to manage multiple assignments with challenging / conflicting deadlines.
  • Salary : $28 - $32

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