The Quality Control Analyst will be responsible for conducting development, validation, routine testing and GMP review of analytical assays in compliance with all applicable quality systems and current cGMPs within the Quality Control department at Spark Therapeutics’ facility in Philadelphia, PA. He/She will support the departmental goals and contribute to general operations and analytical testing within the QC laboratory.
The primary goals of Quality Control are: to lead the execution of release and stability testing for commercial and clinical GMP, execute assay validation and assay transfer studies and critical reagent qualification studies; the implementation and maintenance of laboratory control procedures and compliance; raw materials and laboratory investigations.
• Performs quantitative analytical assays and is experienced with the associated method and instrumentation
• Executes method validation and transfer studies
• Perform routine testing in support of release and stability studies; peer reviews data
• May provide training to other QC analysts
• Participate in maintaining laboratory systems and controls. Active in maintaining the compliance of the laboratory
• Author GMP documents such as analytical methods/forms, technical protocols/reports, CAPAs, and change controls
• With supervision, complete deviation reports and investigations
• Conduct wide variety of assays or tests required to characterize and qualify assay-specific reagents, such as qPCR primers and probes.
• Attend team meetings and project meetings with members from QC.
• With guidance, assist during regulatory audits for their respective assays and interact with regulatory auditors.
• Experience working in a GMP environment is necessary
• Must have an understanding of the science related to the assays they perform.
• Hands on experience in assays performance including: QPCR, PCR, mammalian cell culture techniques, tissue-culture assays, ELISAs, Western blots, etc.
• Possess good interpersonal and strong written/verbal communication skills
• Well developed skills in prioritizing, organization and time management
• Highly motivated and detail oriented with good organizational skills
• Ability to work with minimal supervision; work is reviewed for soundness of judgment and overall adequacy and accuracy
• Delivers routine assignments with general instruction; may provide training to others based upon proficiency in performing task and technical knowledge
• On the job experiential learning, applies intermediate understanding of principles, concepts, etc. to further enhance and develop
• Delivers on work assignments of moderate scope under minimal supervision; resolves and advises on technical issues of a moderate scope
• BA/BS required; and minimum of 2-5+ years related experience
• MS/Ph.D. and a minimum of 3-4+ years related experience
• Frequent internal company contacts
• May need to be available for some weekend scheduled work
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.