ElevateBio

2 weeks ago

Specialist I, QC Logistics (Contract)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

Support QC analytical activities and QC logistics for cell and gene therapy GMP production at ElevateBio. Review outsourced testing protocols, analyze incoming data, and assess deviations/investigations. Coordinate shipping and sample submission processes with contract labs and supply chain, manage QC sample inventory, and help troubleshoot lab issues. Author client-facing documents and manage stability programs, including protocols, trending data, and final reports.

Location: United States

Workplace: Onsite

Employment Type: Contract · Permanent

Job Function: Supply Chain & Logistics

Seniority: Mid level

Key Responsibilities

•Review and analyze testing protocols generated by contract testing laboratories for cell and gene therapy GMP production lots.
•Analyze incoming data and transfer information into internal systems (e.g., LIMS and QMS).
•Review deviations and investigations from outsourced laboratories and assist with in-house reporting as needed.
•Manage logistics for shipping activities and QC sample submission, including labeling, receipt, and inventory management.
•Write and manage stability protocols and programs, including trending stability data and completing final reports.

Pay and Benefits

Salary: USD 43 - 57 hourly

Key Requirements

•Bachelor’s degree in a technical discipline (Biology, Chemistry, Microbiology, Engineering or related) with 3–5 years’ experience in Quality Assurance/Quality Control or a GMP-related role in biotechnology/biologics/pharmaceutical manufacturing.
•Experience with gene and cell therapy test methodologies such as PCR, Flow Cytometry, ELISA/ELISpot, HPLC, and cell-based assays.
•Strong knowledge of GMP, SOPs, and quality system processes.
•Experience writing quality event records including deviations, change controls, and corrective actions.
•Ability to communicate and work independently with scientific/technical personnel.

Experience:3-5 yearsBiotechnologyBiologicsPharmaceutical manufacturingCell and gene therapyGMP

Education:Bachelor's in Biology/Chemistry/Microbiology/Engineering or related field

Skills:CommunicationIndependent workOrganizational skillsData review

Languages:English

Tech Stack:LIMSQMSPCRFlow CytometryELISAELISpotHPLC

Company Brief

ElevateBio

Develops and manufactures cell and gene therapies and provides integrated biologics development and manufacturing platforms, partnering with biotech companies to accelerate clinical and commercial production of advanced therapies.

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Cambridge, United States

Founded: 2017

Website LinkedIn

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ElevateBio

2 weeks ago

Specialist I, QC Logistics (Contract)

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 2 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Contract · Permanent

Job Function: Supply Chain & Logistics

Seniority: Mid level

Key Responsibilities

•Review and analyze testing protocols generated by contract testing laboratories for cell and gene therapy GMP production lots.
•Analyze incoming data and transfer information into internal systems (e.g., LIMS and QMS).
•Review deviations and investigations from outsourced laboratories and assist with in-house reporting as needed.
•Manage logistics for shipping activities and QC sample submission, including labeling, receipt, and inventory management.
•Write and manage stability protocols and programs, including trending stability data and completing final reports.

Pay and Benefits

Salary: USD 43 - 57 hourly

Key Requirements

•Bachelor’s degree in a technical discipline (Biology, Chemistry, Microbiology, Engineering or related) with 3–5 years’ experience in Quality Assurance/Quality Control or a GMP-related role in biotechnology/biologics/pharmaceutical manufacturing.
•Experience with gene and cell therapy test methodologies such as PCR, Flow Cytometry, ELISA/ELISpot, HPLC, and cell-based assays.
•Strong knowledge of GMP, SOPs, and quality system processes.
•Experience writing quality event records including deviations, change controls, and corrective actions.
•Ability to communicate and work independently with scientific/technical personnel.

Experience:3-5 yearsBiotechnologyBiologicsPharmaceutical manufacturingCell and gene therapyGMP

Education:Bachelor's in Biology/Chemistry/Microbiology/Engineering or related field

Skills:CommunicationIndependent workOrganizational skillsData review

Languages:English

Tech Stack:LIMSQMSPCRFlow CytometryELISAELISpotHPLC

Company Brief

ElevateBio

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Established Company

Headquarters: Cambridge, United States

Founded: 2017

Website LinkedIn