QA Validation Specialist II
QA Validation Specialist II
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Salary Not Disclosed
1 Vacancy
Job Description
- Previous Cell and Gene therapy experience a must.
- Elevate Bio is looking for a contractor as a Specialist II to join their growing QA Validation group. This is expected to be a 6-month contract position. The role is expected to be onsite in Waltham MA 3-4 days per week.
- 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 CMMS records related to asset management including asset release database requests and work orders.
- Author and perform review of SOPs in Veeva.
- Bachelors 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.
- Prior experience working with contract manufacturing preferred.
- Experience with Kneat strongly preferred.
Employment Type
Full Time
