Elevatebio
Specialist I, QC Logistics (Contract)
Waltham, Massachusetts, United States
Sponsorship not specified$15k-$20kDetected 23 days ago
Data AnalysisSupply ChainLogisticsInventory ManagementGMPPCRCRISPRFlow CytometryMass SpectrometryProtein AnalysisCommunication
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odds of building a lasting career here
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Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
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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
- 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.
- Manage logistics of shipping activities between contract manufacturing organization, investigators, and contract testing laboratories for both routine testing and investigational work.
- Author and manage change controls associated with ElevateBio processes and client requested changes.
Requirements
- Bachelor's degree and at least 3 years of experience, OR Master's degree with up to 1 year of experience.
- 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
- 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 PPE.
Nice to have
- Experience in cell and gene therapy manufacturing environment is a plus
Skills
- Analyze incoming data and transfer information into internal systems (e.g. LIMS and QMS).
- Review deviations/investigations from outsourced laboratories.
- Handle internal QC sample submission process which includes labeling and sample receipt.
- Manage QC sample inventory.
- Writing stability protocols and managing stability testing and data review.
- Routine client and internal cross functional communication
Compensation
- $15k-$20k
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This listing is sourced directly from Elevatebio's careers page and normalized into a canonical job model.