Specialist , QC Logistics

at Elevate Bio

Waltham, MA - Smith

Department: Quality Control

Employment Type: Contractor

Elevate Bio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

The QC Specialist I, Logistics will support QC analytical activities outsourced to contract testing laboratories as well as QC logistics s role will require the comprehension of assay protocols and review of data analysis and reports of executed testing. 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.

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 Elevate Bio. The role will also require management of stability programs from writing stability protocols to trending stability data and completing final reports.

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.

• Review/analyze testing protocols generated by contract testing laboratories for cell and gene therapy GMP production lots including engineering and clinical material.
• Analyze incoming data and transfer information into internal systems (e.g. LIMS and QMS).
• Review deviations/investigations from outsourced laboratories.
• 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.
• Handle internal QC sample submission process which includes labeling and sample receipt.
• Manage QC sample inventory.
• Author and manage change controls associated with Elevate Bio processes and client requested changes.
• Writing stability protocols and managing stability testing and data review.
• Routine client and internal cross functional communication

• Bachelor’s degree and at least 3 years of experience, OR Master’s degree with up to 1 year of experience.
• Preferred technical discipline (Biology/Chemistry/Microbiology/Engineering or related field) with experience in Quality Assurance, Quality Control, or a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
• 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.
• Excellent organizational skills.
• Experience in cell and gene therapy manufacturing environment is a plus
• Experience performing laboratory investigations

• Ability to stand, walk, bend and stretch for extended period of time
• Ability to lift 15-20 lbs
• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing…