Elevatebio
Specialist I, QC Logistics (Contract)
Waltham, Massachusetts, United States · Contract
Sponsorship not specifiedDetected 13 days ago
Data AnalysisSupply ChainLogisticsInventory ManagementGMPPCRCRISPRFlow CytometryMass SpectrometryProtein AnalysisCommunication
About the role
- This role will require the comprehension of assay protocols and review of data analysis and reports of executed testing.
- This role will also require supporting the outsourced testing logistics such as sample submission documentation, scheduling shipments with supply chain, material pack out, and tracking samples once submitted.
- The QC Specialist I will assist in QC sample management, such as labeling and receipt, and inventory management within ElevateBio.
Responsibilities
- Manage logistics of shipping activities between contract manufacturing organization, investigators, and contract testing laboratories for both routine testing and investigational work.
- May perform optimization and troubleshooting experiments at Elevatebio laboratories.
- Manage QC sample inventory.
- Author and manage change controls associated with ElevateBio processes and client requested changes.
- The QC Specialist I, Logistics will support QC analytical activities outsourced to contract testing laboratories as well as QC logistics at ElevateBio.
- This role will support the review of investigation and deviation reports generated by the testing laboratories and may assist in the preparation of in-house reports associated with these events.
- The Specialist I will author and manage client documents such as, but not limited to, product sampling plans, specifications, and certificates of analysis.
- Additionally, this role will have regular communication with clients to support daily operations as described above.
Requirements
- Experience with typical gene and cell therapy test methodologies (PCR, Flow Cytometry, ELISA/ELISpot, HPLC and cell-based assays).
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMP, SOPs, and quality system processes.
- Experience writing quality event records such as deviations, change controls, and corrective actions.
- Experience performing laboratory investigations
Nice to have
- Experience in cell and gene therapy manufacturing environment is a plus
Apply directly at Elevatebio →Create a free account for alerts like thisView Elevatebio immigration profile
This listing is sourced directly from Elevatebio's careers page and normalized into a canonical job model.