Elevatebio
Senior Specialist II, Quality Control Validation
Waltham, Massachusetts, United States · Senior
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
This range already reaches Level IV — the maximum four lottery entries.
DOL prevailing wage, 2026-27 wage year · Logisticians (13-1081) · Boston-Cambridge-Newton, MA-NH. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- The Senior Specialist II, QC Validation role l is responsible for overseeing method validation and overall validation readiness within Quality Control at our Manufacturing facility.
- In addition, this position will work closely with the Analytical Development, QC management, QC testing, and QA teams, as well as customers to ensure that validation objectives are met.
- Analyze associated data and report validation results.
Responsibilities
- Collaborate with QC testing functions (i.e. QC Microbiology, QC Raw Materials and QC Outsourcing) to ensure all testing is initiated and completed within established timelines.
- Ensure test methods, associated equipment/software, and associated SOPs are appropriate for validation in preparation for commercial manufacturing. Collaborate on and oversee change controls, as needed.
- Support inspections and facility audits.
Requirements
- Expertise with gene and cell therapy test methodologies (qPCR/ddPCR, Flow Cytometry, ELISA, and cell-based assays).
- Ability to communicate and work independently with scientific/technical personnel.
- Strong knowledge of GMPs, SOPs, and Quality system processes.
- Experience with method validations for commercial products.
- Ability to stand, walk, bend and stretch for extended period of time
Nice to have
- Experience in cell and gene therapy manufacturing environment is a plus.
- Experience working with electronic systems (LIMS, CMMS, QMS, ERP) is a plus.
Compensation
- This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law
This listing is sourced directly from Elevatebio's careers page and normalized into a canonical job model.