Assistant Scientist (Clinical QC Sample Management)

Job Description

Job Description

Job 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.

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.

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,

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.

Position Handles Hazardous Materials

Qualifications :

Bachelor's 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.

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

Benefits :

Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.