QC Analyst
- Employer
- Spark Therapeutics
- Location
- Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
- Salary
- Salary not provided
- Closing date
- Jun 8, 2022
View more
- Discipline
- Other, Manufacturing/QA/QC
- Organization Type
- Pharma
Job Details
- 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
- MS/Ph.D. and a minimum of 3-4+ years related experience
- 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.
- 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.
- 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.
Nearest Major Market: Philadelphia
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.
Company
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.
Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.
Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.
- Website
- http://sparktx.com/
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