Share this Job

Senior Quality Control Data Review Specialist

Date: Sep 8, 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.

 

  • Perform Quality Control data review in both paper-based and in electronic format (i.e. LIMS), to ensure technical accuracy, compliance and data integrity
  • Work with laboratory management and analysts to address quality impacting issues identified during review
  • Work with QA and other stakeholders on ensuring QC data integrity
  • Author and revise SOP, deviation, investigation, Change Control and CAPA
  • Support audits and regulatory inspections
  • Performs other duties as assigned
  • Train junior team members

 

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

70

  • Review raw data, audit trails, as well as study reports, records that support lot release, stability, method validation, and other analytical studies. 
  • Collaborate with analyst and lab management to address issues identified during data review.

30

  • Author and revise SOP, deviation, investigation, Change Control and CAPA
  • Improve data integrity by collaborating with internal and external stakeholders
  • Develop training material and provide training as data review SME
  • Support audit and inspection

 

 

Requirements

  • BS, MS or PhD in biological, chemical sciences, or related discipline.
  • 10+ years for BS, 5+ years for MS, 3+years for PhD, of related experience in the Pharmaceutical/Biotech industry working in a GMP/regulated environment.
  • Thorough knowledge in LC/MS, HPLC, CE-SDS, MADLS methods for protein and viral vector characterization and compendial assays.
  • Previous GLP/GMP data review experience.
  • General knowledge of virology, microbiology and molecular biology assays preferred.
  • Experience in analytical instrument audit trail review preferred.
  • Experience with LIMS and electronic lab notebook preferred,

#LI-AK1

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