This job has expired

QC Analyst

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
May 25, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
Pharma
You need to sign in or create an account to save a job.

Job Details

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.

Responsibilities

  • 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.
Education and Experience Requirements

  • BA/BS required; and minimum of 2-5+ years related experience
– OR-

  • MS/Ph.D. and a minimum of 3-4+ years related experience

Key Skills, Abilities, and Competencies

  • 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.
Complexity and Problem Solving

  • 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.
Internal and External Contacts

  • Frequent internal company contacts
Other Job Requirements

  • 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.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert