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Sr QC Systems Specialist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
May 11, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
Pharma
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Job Details

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.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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