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Quality Control Sample/Document Coordinator
Job Opportunity at
Spark Therapeutics, Inc
Posted on Apr 8
The Quality Control Coordinator will be responsible for samples receipt and management at the QC laboratories, as well as shipping samples to contract organizations. S/he will be responsible for coordinating internal testing, managing paperwork, compiling and archiving data package. S/he will assist in generating and revising GMP documents such as SOP and ensuring GMP-controlled copies are maintained within the laboratory. This person will be responsible for laboratory housekeeping, assist to schedule equipment maintenance and ensure the lab equipment within calibration, and coordinate the training program within QC department.
Receive samples and associated paperwork at the QC laboratory, log in the samples into QC system, and store the samples properly.
Distribute samples to analysts for testing and control the sample flow at the QC lab.
Dispose samples properly after testing completion.
Ship samples to contract organizations as requested.
Prepare controlled paper printout for internal assays, coordinate the testing flow from assay initiation to completion.
Compile and archive data package.
Reconcile GMP controlled paper printout.
Develop and maintain department metrics for tracking the turnaround time on assay initiation, completion, and data review.
Assist in generating and revising GMP documents such as SOP.
Perform regular QC laboratory cleaning and ensure laboratory is in good shape.
Ensure all lab logbooks are reviewed.
Assist in ensuring equipment in QC lab within calibration.
Assist to schedule equipment maintenance, as needed.
Coordinate training program in the QC department as appropriate.
Possess good interpersonal and strong written/verbal communication skills
Well-developed skills in prioritizing and time management
Highly motivated and detail oriented with good organizational skills
Possess the ability to multitask and work independently and in a regulated environment with general supervision
Associate or Bachelor degree in biology, chemistry, or related discipline.
Generally, has 1-4 years of related experience in the pharmaceutical industry.
Experience with biopharmaceutical products or vaccines a plus.
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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