Demo

Associate Scientist - QC

BCForward
Warren, NJ Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 5/29/2025

Job Description

Job Description

Job Title : Associate Scientist – QC Sample Management

Location : Warren, New Jersey - 07059

Duration : 6 Months

Working Schedule : Mon – Fri (100% Onsite)

Description :

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.

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

Duties and 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.
  • Education and Experience

  • Bachelors 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.
  • Company Description

    About BCforward :

    Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally.

    BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work.

    BCforward is an equal opportunity employer.

    Company Description

    About BCforward : Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward’s 6,000 consultants support more than 225 clients globally. BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class places to work. BCforward is an equal opportunity employer.

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