Qc Data Reviewer Jobs

QC Data Reviewer

• 6-12 month contract to extend or convert
• On-site near Billerica, MA area

Summary

The QC Data Reviewer will support QC activities in the field of AAV therapeutic release and stability both internally and at CTLs and CMOs. Day to day responsibilities include reviewing data from routine testing, validations and qualifications. In addition, the QC Data Reviewer will generate certificates of analysis/testing (CoA/CoTs), standard operating procedures (SOPs), provide oversight of CTLs, assist in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and assist in data trending.

Responsibilities

• Support method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents and reference material.
• Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, ddPCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOs, and internally.
• Monitor, compile, and review analytical and QC data
• Create and maintain records and documentation.
• Trend data for qualified materials, release products, and stability products.
• Assist team with coordination of sample pulls, set downs, and tracking critical reagents.
• Assist in writing and reviewing quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally and at vendor sites.
• Act as company liaison with CMOs to coordinate in method development, method transfer, and release and stability testing across various sites as needed.
• Author and review test methods, development reports, study protocols, and validation reports.

Qualifications

• Familiarity with compendial (USP, ICH, EP) guidance is highly desired.
• B.S. or M.S. degree with at least 2-5 years relevant experience.
• A strong understanding of cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays.
• Working experience in a cGMP environment is preferred.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

To find out more about Real please visit www.realstaffing.com