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Quality Control Analyst

Date: May 28, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

 

 

Primary Duties:

 

The Quality Control Analyst will be responsible for conducting development, validation, routine testing, non-routine 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.

 

 

Responsibilities:

% of Time

Job Function and Description

60%

  • Perform QC testing using qPCR, ddPCR and/or cell-based assays such as ELISAs, and Western Blots.
  • Execute and review of Bio-Analytical assays for release and stability purposes in a GMP-compliant QC laboratory. 
  • Provides assigned assay-related technical expertise in cross-functional teams and perform optimization, transfer, qualification, and validation for lot release testing of clinical drug product within a GMP environment.
  • Perform routine testing in support of release and stability studies, peer reviews data.
  • Participate in the evaluation of emerging data and trending analysis.

20%

  • May provide training to other QC analysts.
  • Participate in laboratory maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.
  • Active in maintaining the compliance of the laboratory.
  • Author and review GMP documents such as analytical methods/forms, technical protocols/reports, CAPAs, and change controls.
  • With supervision, complete deviation reports and laboratory investigations.

10%

  • Conduct wide variety of assays or tests required to characterize and qualify assay-specific reagents, such as qPCR primers and probes.

10%

  • 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 3-4+ years related experience

 – OR-

  • MS/Ph.D. and a minimum of 2+ years related experience

 

Key Skills, Abilities, and Competencies:

 

  • Experience working in a GMP environment is necessary.
  • Experience in molecular biology and gene therapy research. 
  • Demonstrated expert ability in qPCR and ddPCR techniques.
  • Experience in cell-based assays, e.g. ELISA, SDS-PAGE, Western Blot is a plus. 
  • Strong scientific, analytical, problem solving, and communication skills, with the ability to work both independently and effectively with others.
  • 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.
  • 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 in a high-paced team environment, meet deadlines and prioritize work from multiple project s with little supervision.

 

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.

 

 

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Nearest Major Market: Philadelphia