QC Associate Analyst

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 unlock the power of gene therapy to accelerate healthcare transformation.

We don't follow footsteps. We create the path.

Primary Duties

The Quality Control Associate Analyst will be responsible for conducting validation, routine testing and GMP review of analytical assays in compliance with all applicable quality systems and current cGMPs within the Quality Control department at Spark Therapeutics' facility in Philadelphia, PA. They will support the departmental goals and contribute to general operations and analytical testing within the QC laboratory.

The primary goals of Quality Control are to lead the execution of release and stability testing for commercial and clinical GMP, execute assay validation and assay transfer studies and critical reagent qualification studies, the implementation and maintenance of laboratory control procedures and compliance, raw materials and laboratory investigations.

Responsibilities

• Execute and review of qPCR and DNA based assays for release and stability testing in a GMP-compliant QC laboratory.
• Perform quantitative analytical assays and is experienced with the associated method and instrumentation.
• Execute method validation and transfer studies.
• Perform routine testing in support of release and stability studies.
• Participate in maintaining laboratory systems and controls. Active in maintaining the compliance of the laboratory.
• Author GMP documents such as analytical methods/forms, technical protocols/reports, CAPAs, and change controls.
• With supervision, complete deviation reports and investigations.
• Conduct a wide variety of assays or tests required to characterize and qualify assay-specific reagents.
• Attend team meetings and project meetings with members from QC.

Education and Experience Requirements

• BA/BS required; and minimum of 1-3+ years related experience-OR- MS/Ph.D. and a minimum of 0-2+ years related experience.
• Experience working in a GMP environment is necessary.
• Must have an understanding of the science related to the assays they perform.
• Background experience in executing qPCR and PCR Assays.
• Must have experience with Quantstudio Software.
• Hands on experience with bioanalytical assay methods such as SDS-PAGE, ELISA, spectrophotometry, SEC, CE-SDS, ddPCR and cell culture, preferred.
• May need to be available for some weekend scheduled work.

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $50,200 to $75,200.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.