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Sr. QC Systems 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.

The Sr Quality Control System Specialist will serve as administrator for all QC laboratory computerized systems.  This position will be the point-contact person in the Quality Control and Analytical Sciences department for any systems related issues or requests.

 

The Sr Quality Control Systems Specialist will serve as a system administrator for LabWare LIMS, Empower3, and stand-alone systems.

 

This role will report into the QC Systems Lead and will also be expected to advise and provide input into the overall systems strategy. S/he will also lead and/or participate in projects and initiatives related to continuous improvement and data integrity. Work with the end-users to ensure that projects are built around business needs.

 

Specific responsibilities include:

  • Serve on systems projects to help lead and provide input on systems strategies
  • Deliver on Continuous Improvement opportunities
  • System Administrator Role in the QC LIMS system
  • Administration and Oversight of the Empower3 System
  • Serve as administrator for QC stand-alone laboratory systems
  • Collaborating Cross-Functionally to Deliver QC Data integrity initiatives
  • Ensure compliance of QC laboratory computerized system
  • Troubleshooting of computerized instrumentation across QC
  • Oversee Computerized System Training for QC/AS Team for Empower and LIMS
  • Participate in QC Computerized Systems Investigations, as required.
  • Assist as SME on Regulatory Audits

 

Responsibilities

% of Time

Job Function and Description

35%

Customer Delivery as System Admin

  • User Accounts Creation/Modify/Disable
  • User Audits across Systems
  • Resolve System Issues
  • Admin over Empower 3, LIMS, and stand-alone systems

30%

Data Integrity

  • Serve as Subject Matter Expert on Regulatory Audits
  • Collaborate Cross-Functionally to Deliver QC Data Integrity Initiatives
  • Provide Input and Guidance on Project Work

25%

Continuous Improvement Initiatives

10%

Oversee Computerized System Training for the QC/AS Team

  • Empower and LIMS Training Programs

 

Education and Experience Requirements

  • BS or MS degree in biological or chemical sciences
  • Generally has a minimum of 5+ years of related work experience in a GMP laboratory environment
  • Experience with biopharmaceutical products, biologics preferred
  • Must have strong GMP experience and strong GMP documentation skills
  • Must have previous experience serving as system administrator for GXP systems.
  • Must have strong Empower Administrative experience
  • Must have excellent customer-service oriented mindset
  • Previous experience in continuous improvement initiatives and projects.


Key Skills, Abilities, and Competencies

  • Ability to multi-task and work in a regulated environment
  • Ability to prioritize and deliver on agreed-upon timelines 
  • Excellent communication skills, both oral and written
  • Ability to develop solutions to a variety of problems of moderate scope and complexity while exercising judgment within defined procedures and practices to determine appropriate actions
  • Ability to build productive working relationships internally and externally
  • Ability to work with limited supervision; work is reviewed for soundness of judgment and overall adequacy and accuracy

 

Complexity and Problem Solving

  • The incumbent is expected to have sufficient experience and knowledge of LIMS, SDMS, and electronic laboratory systems.
  • The incumbent must be proficient on routinely used laboratory software, such as EMPOWER, SoftMax, and QuantStudio to proactively identify potential system issues and raise the concerns to management as well as provide options for a path forward based on previous experience. 
  • The incumbent is also expected to ensure the QC laboratory computerized system compliance with 21 CFR Part 11.

 

Internal and External Contacts

  • This job advises the QC Systems Lead on system strategy.
  • The position serves as the administrator for all QC laboratory computerized system, and point to contact person in the Quality Control and Analytical Sciences department for any system related issues.
  • The position also interacts directly with cross functional group and outside vendors to implement electronic systems.

 

Other Job Requirements

  • Some off-shift and weekend hours may be required

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