The Sr. QC Technical Specialist is a critical member of the QC team. He/she is responsible providing quality and technical support to the QC Analysts and QC Leads and Leaders. He/she is responsible for ensuring compliance in the laboratory in accordance with cGMPs, international regulations and Spark procedures. The Sr. QC Technical Specialist will be responsible for:
• Meet and driving changes to ensure technical support needs are met, including schedule adherence and right the first time execution of testing.
• Providing guidance for necessary analytical changes in partnership with Analytical Sciences and QC Leads and Leaders.
• Supporting Spark QC key projects aimed at elevating the compliance and performance of the QC laboratory.
• Reviewing documentation generated by Spark QC and Contract Testing Laboratories (CTL) for accuracy and GDP, as assigned by Functional Management
• Generating and review SOP’s, Technical Documents, Technical Protocols and Reports for the Technical Operations team.
• Performing non-conformance (OOT/OOS) investigations, CAPAs, and change controls associated with both insourced and outsourced testing.
• Supporting Spark QC in regulatory inspections.
• Perform complex QC testing, particularly cell-based assays, to support clinical and commercial product release
• Provide real-time technical support to the QC Analysts
• Support management of daily operations of Quality Control Biochemistry group (self-inspection program, Laboratory logbook review, …)
• Schedule testing for Quality Control Biochemistry group according to Department and Company priorities.
• Assist the QC Compliance Lead and generate policies, procedures and Technical Protocols/Reports related to QC testing.
• Assist the QC Compliance Lead with Data Review.
• Act a Lead Investigator in Deviation/Investigations and OOS/OOT Investigations.
• Support management of QC equipment and instrument in collaboration with QC Stability & Systems and Facilities.
• Support and review of regulatory submissions.
• Support Spark during audits and regulatory submissions.
• Routine support of Technical Operations (Manufacturing, MS&T, Facilities) as assigned by Functional Management
• High attention to details; ability to identify errors and incompleteness of lab generated documents;
• Proven extensive technical writing experience with the ability to provide work examples of such experience;
• Proven analytical aptitude, critical thinking skills and ability to apply key concepts;
• Proven ability to manage multiple tasks/projects simultaneously;
• Ability to work independently and manage work to defined schedules;
• Team work spirit and excellent people skills;
• In-depth understanding of biological and molecular assays
• BS or MS degree required in relevant scientific discipline (such as molecular biology, biochemistry or virology);
• For candidates with a Bachelor’s degree, a minimum of 7 years of experience in a GMP environment is required, including hands-on experience in cell-based assay and qPCR assay development;
• For candidates with a Master’s degree, a minimum of 5 years of experience in a GMP environment is required including hands-on experience in cell-based assay and qPCR assay development;
• Experience in QC or QA review of lab generated records and data within the pharmaceutical/regulated industry;
• Experience in pharmaceutical laboratory operations or related environment;
• In-depth working knowledge and application of cGMPs and regulatory guidance;
• Excellent written and verbal communication skills.
About Spark Therapeutics
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.