Elevatebio
Lead Specialist, QA Validation
Waltham, Massachusetts, United States · Contract
Sponsorship not specified$15k-$20kDetected 7 days ago
ExcelGMPCRISPRProblem SolvingWritingMicrosoft Office
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odds of building a lasting career here
37Risky
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
Thin sponsorship signal and lottery-bound (~15% per draw). A low-probability bet with your clock running. Prioritize cap-exempt roles and proven entry-level sponsors first.
Lottery odds assume a STEM candidate.
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About the role
- Recognized as quality expert for these programs and acts as direct escalation pathway for teams.
- Scope inclusive of manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
- The candidate will contribute to team based collaborative environment promoting commitment to continuous improvement and achievement of goals within the QAV group.
Responsibilities
- Independently evaluates CQV change controls by authoring impact assessments and provides QA support and approval for associated CQV activities.
- Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.
- Potential to provide administration support for Kneat electronic validation system.
- Leads QA oversight and support for periodic review and requalification activities.
- Manage team of QAV personnel including both FTE and contractor resources
Requirements
- Bachelor's degree and at least 5 years of related experience
- or Master's degree with at least 3 years of related experience
- or a PhD with up to 1 year of related experience.
- Strong knowledge of 21 CFR, ICH, EU regulations
- Experience with Blue Mountain CMMS system desired.
- Strong technical writing skills and proficiency in various computer programs (Word, Excel, PowerPoint, Kneat, Veeva, Blue Mountain CMMS)
- Ability to stand, walk, bend and stretch for extended period of time
Nice to have
- Prior experience in Cell and Gene Therapy manufacturing a plus.
- Prior management experience a plus.
- Experience in new facility commissioning and qualification preferred.
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
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