45 applicants
ElevateBio · 3 days ago
Specialist II, QA Validation
Waltham, MA
Full-time
Onsite
Mid, Senior Level
5+ years exp
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Responsibilities
Provide QA oversight of CQV activities for the cGMP manufacturing facility and quality control laboratories.
Provide QA oversight for periodic review and requalification program.
Perform review of quality records including deviations, CAPAs, and change controls.
Evaluate changes to qualified assets and author impact assessments and related quality records.
Perform review of CMMS records related to asset management including asset release, database requests, and work orders.
Author and perform review of SOPs in Veeva.
Work cross-functionally to identify and implement CAPAs from related deviations or based on opportunities for improvement.
Liaise with project teams to develop project schedules, escalate issues, track milestones, and ensure adherence to program timelines.
Provide administration support for Kneat electronic validation system.
Qualification
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Required
Bachelor’s degree in a technical discipline with 5+ years validation and/or quality assurance experience. In lieu of degree, 7+ years of equivalent work experience is required.
Knowledge of 21 CFR, ICH, EU Regulations, GAMP 5, risk-based validation.
Prior experience working in cell and gene therapy manufacturing preferred.
Prior experience working with contract manufacturing preferred.
Experience with Kneat strongly preferred.
Applies collaborative approach to problem solving and is experienced with risk-based decision making.
Team player who works well in large multi-disciplinary project groups by listening effectively and inviting open discussion.
Company
ElevateBio
ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come.
201-500 employees
H1B Sponsorship
ElevateBio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (14)
2022 (7)
2021 (1)
2020 (1)
Funding
Current Stage
Early StageTotal Funding
$14M2021-03-23Angel· $14M
Leadership Team
Vikas Sinha
Chief Financial Officer
Michael Paglia
Chief Operating Officer, ElevateBio BaseCamp
Recent News
2024-05-10
2023-12-06
Company data provided by crunchbase
