The Quality Control Analyst will be responsible for FIO testing, qualification, 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 qualification/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.
Education and Experience Requirements
- Execute and review of Bio-Analytical assays for release and stability purposes in a GMP-compliant QC laboratory.
- Performs quantitative analytical assays and is experienced with the associated method and instrumentation.
- Executes method qualification/validation and transfer studies.
- Perform routine testing in support of release and stability studies; peer reviews data.
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.
- BA/BS required; and minimum of 2-5+ years related experience
Key Skills, Abilities, and Competencies
- MS/Ph.D. and a minimum of 3-4+ years related experience
Complexity and Problem Solving
- Experience working in a GMP environment is necessary.
- Hands on experience in the following areas, qPCR, ddPCR, mammalian cell culture techniques, ELISAs, and SDS-PAGE.
Must have an understanding of the science related to the assays performed.
Keep accurate records, follow instructions, and comply with company policies. Familiarity with Laboratory Information Management Systems (LIMS) a plus.
- Possess good interpersonal and strong written/verbal communication skills.
- Critical thinking skill, ability to manage time, and 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.
Internal and External Contacts
- 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.
Other Job Requirements
- Frequent internal company contacts
- May need to be available for some weekend scheduled work
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.
We don't follow footsteps. We create the path.