Share this Job

Senior Quality Control Data Review Specialist

Date: Feb 22, 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.

 

 

This position will be responsible for managing the review and approval of all GMP data generated by QC and contract testing organizations, including paper and electronic data.  Under the general guidance of the QC Data Review Lead, s/he will work independently to ensure data integrity and all GMP/GDP and regulatory requirements are met.

The responsibilities include but not limited to:

  • Review laboratory records and test results, both paper-based and in electronic format (i.e. LIMS), including audit trails, for completeness and accuracy
  • Ensure the assay records and related information are compliant to test method, procedures, specifications, cGMP, and internal SOP requirements and scientifically sound
  • Communicates with analysts and laboratory managers to proactively address quality impacting issues
  • Provide support as required to address data related issues internally or in collaboration with other departments as a member of a cross-functional team.
  • Contribute to the data integrity improvement project
  • Author and revise SOP, investigation, CAPA
  • Support audits and regulatory inspections
  • Performs other duties as assigned
  • Train junior team members

 

Responsibilities

70%       Review internal GMP assay records and results and electronic data, as well as contract testing lab’s reports, records, and data to support lot release and other QC studies.  Review audit trails of instruments.  Author and revise SOP, deviation, investigation, and CAPAs. Collaborate with analyst and management to address issues identified during data review.

 

30%       Work with internal and external stake holders to improve data integrity by strengthening data review process.  Train new team members.  Provide support to 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

 

  • Previous GLP/GMP data review experience

 

  • Thorough knowledge of virology, microbiology, and compendial assays, such as viral safety, bioburden, endotoxin, growth promotion, pH, Osmolality, viral titer, impurity and potency testing.

 

  • General knowledge of other analytical assays is a plus

 

  • Experience in analytical instrument audit trail review preferred

 

  • Experience in data review in LIMS preferred

 

  • Experience in process improvement

 

  • Experience of training

 

Competencies

  • Highly motivated
  • Attention to detail and organized
  • Deep understanding of laboratory procedures, methodology, standards, and data integrity principles
  • Strong verbal and written communication skills
  • Ability to adapt to priority changes and/or new knowledge/concept
  • Ability to provide clear and concise feedback and/or documentation of results
  • Ability to work in a collaborative team environment
  • Ability to work independently or with minimum supervision
  • Ability to multitask and to arrange time based on project priority May have exposure to potentially hazardous elements typically found in healthcare of laboratory environments

#LI-NBL1


Nearest Major Market: Philadelphia