Associate Scientist - QC Sample Management
Associate Scientist - QC Sample Management
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Job Description
Job Title: Associate Scientist QC Sample Management
Job Location: Warren NJ USA
Job Location Type: Remote
Job Contract Type: Contract
Job Seniority Level: Entry level
Job Number:
Be part of a company that delivers lifechanging 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.
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.
- 23 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
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical Dental & Vision Insurance through ECLARO
If interested you may contact:
June Binuya
June Binuya LinkedIn
Equal 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.
Employment Type
Full Time
