eGenesis
Senior Quality Systems Specialist
Cambridge, MA · Senior
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). 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
$12,933 more — $119,933 — moves this role to Level III and 3 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $119,933 would place this position at wage Level III. That figure is within the posted range, and I'd like to target it. This role classifies under "Industrial Engineers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Industrial Engineers (17-2112) · 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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from this employer's Department of Labor filings
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- This position reports to the Associate Director of Quality Systems and is a highly visible and impactful position that will require cross-functional interaction across the multiple teams in the Organization.
Responsibilities
- Developing, implementing, and maintaining processes to support QA oversight for the manufacturing of material to be used in clinical studies
- Ability to initiate, support and manage deviations and CAPAs ensuring timely closure across all sites
- Responsible for Documentation Management (archival of physical records, management of Document Change Controls etc.)
- Responsible for Organization Training including administering training, managing training matrices, trending metrics and further developing the Training Program
- Developing, trending, and reporting of relevant Quality Metrics associated with the area of responsibility
- Provide Quality Assurance support to many cross functional teams including Development, Manufacturing, Quality Control departments
- Implement process improvements to enhance compliance and improve method and product quality processes (e.g. process tools creation, SOP revision, or enterprise systems implementation)
- Provide Quality Assurance support in reviewing/approving executed records in needed areas (Forms, Logbooks, Master Batch Records etc.)
- Perform duties regarding special projects, as assigned by QA Management
Requirements
- Bachelor's degree in a scientific or operational discipline relevant to the life sciences or biopharma areas with 5+ years combined of experience in quality system management
- Non-degreed candidates with 7+ years combined of relevant GLP/GMP quality systems experience will be considered
- Knowledge of Quality Management Systems (QMS), CAPA processes, and audit procedures
- Familiarity with relevant regulations and standards (e.g., ISO, FDA, cGMP)
- Strong analytical, problem-solving, and communication skills
Nice to have
- Proficiency in using QA software tools and electronic Quality Management Systems (eQMS) is a plus
Compensation
- $107k-$138k
Company info
- At eGenesis, our core values -innovation, collaboration, compassion, resilience, and passion-are at the center of how we work.
This listing is sourced directly from eGenesis's careers page and normalized into a canonical job model.