Sr QC Systems Specialist

Spark Therapeutics
San Francisco, California
Salary not provided
Closing date
May 22, 2022

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Pharmaceutical, Supply Chain, Quality Assurance
Organization Type
Jobseeker Type
The Senior QC Systems Specialist will serve as business system administrator for QC laboratory computerized systems. This role serves as the point of contact in the Quality Control and Analytical Sciences department for any systems-related issues or requests.

The Senior Quality Control Systems Specialist may serve as the business system administrator and subject matter expert for the LabWare LIMS system, and stand-alone systems including QuantStudio, Empower3, UV-Vis, SoftMax, LabX, 32Karat, ZetaSizer, and other systems.

This role reports into the QC Systems Lead. S/he will also lead and/or participate in projects and initiatives related to continuous improvement and data integrity pertaining to the computerized systems within this function.

Specific responsibilities include:
  • Provide support and guidance on cross-functional projects
  • Business System Administrator Role in LabWare LIMS
  • Serve as business administrator for QC stand-alone laboratory systems
  • Ensure compliance of QC laboratory computerized system
  • Troubleshooting of computerized instrumentation across QC
  • Support and Sustain Training as applicable

Job Function and Description
Customer Delivery as Business System Administrator
  • User Account Management
  • Troubleshoot System-related Issues
  • Project support and guidance
Data Integrity
  • Collaborate Cross-Functionally to Support QC Data Integrity Initiatives
Continuous Improvement Initiatives
Education and Experience Requirements
  • At a minimum, a BS degree in the biological or chemical sciences
  • Generally has a minimum of 5+ years of related work experience in a GMP laboratory environment
  • Must have strong GMP experience and strong GMP documentation skills
  • Must have excellent customer-service oriented mindset
Key Skills, Abilities, and Competencies
    Ability to multi-task and workin a regulated environment Ability to prioritize and deliver on agreed-upon timelines Excellent communication skills, both oral and written Excellent follow-up skills Ability to build productive working relationships internally
Complexity and Problem Solving
  • The incumbent is expected to have strong follow-up and customer delivery mindset.
  • The incumbent is also expected to ensure the QC laboratory computerized system compliance with 21 CFR Part 11.
Internal and External Contacts
  • The position serves as the business administrator for all QC laboratory computerized systems, and serves as the point of contact in the Quality Control and Analytical Sciences department for system-related issues. This role works externally with CQV, CSV, IT, and QC operations.

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

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.

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