QC Sample and Data Control Lead

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 QC Sample and Data Control Lead will manage the QC sample and data control team to ensure proper controls are in place for managing QC GMP testing. S/he is also responsible for QC critical reagent and reference standard inventory management and for monitoring testing progress and provide project update.  The responsibilities include, but not limited to the followings: 

• Manage the day-to-day operation of the sample and data control team and make timely adjustment based on priorities;
• Lead the process improvement projects to ensure operational/compliance excellence;
• Author, review, and approve SOPs, deviations, and investigations;
• Drive the initiation, implementation and completion of CAPAs and Change Controls;
• Monitor project progress and provide update to leadership;
• Develop and maintain QC operational metrics and provide updates to leadership;
• Serve as SME in regulatory agencies inspections;
• Serve as SME in LIMS implementation and enhancement

Responsibilities

40%       Oversee the day-to-day operation. Review Quality Control documents Manage and coordinate Critical Reagent and Reference Standard inventory management. Monitor QC project progress. Provide project updates.

30%       Work on the process improvement for QC sample and data control.  Develop and maintain operation metrics.  Author/review SOPs and other quality documents. Drive the closure of CAPAs and Change Controls.

15%       Serve as SME in LIMS operation.  Provide instruction on LIMS’s sample and data control enhancement.  Serve as business representative for the team for new system and infrastructure establishment. 

15%       Provide training and guidance to team members to promote high-quality performance.  Support individual/team growth and development.  Cultivate positive environment for collaborations and operational excellence.

Requirements

• BS biological or chemical sciences required; higher degree preferred 
• Minimum of 7+ years’ experience for BS, 5+ years for MS or higher in the Pharmaceutical/Biotech industry working in a GMP/regulated environment
• Solid knowledge in GMP requirement and regulation
• Experience in team management
• Experience in sample and critical reagent management and/or data management
• Experience in using LIMS for sample and data management
• Experience in project management preferred
• Experience in QC testing preferred
• Experience in regulatory inspection preferred

Competencies

• Great communication skills
• Excellent ability in prioritization and time management
• Highly motivated and adaptive
• Detail oriented with good organizational skills

• Proficient in using Microsoft software, expert in Excel preferred
• Good at multitasking