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QC Analyst

Date: Aug 14, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Summary

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.

 

SUMMARY

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.

 

Responsibilities

             60% 

  • 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

20% 

  • 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

20% 

  • 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.

 

 

 

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
Competencies
  • 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
  • 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


Nearest Major Market: Philadelphia