What are the responsibilities and job description for the Quality Assurance Validation position at Intellectt Inc?
Job Description: Quality Assurance Validation (QAV) Position
Location: Boston, MA
Contract Duration: 6 Months (Long Term)
Eligibility:
- Minimum 6 years of professional experience working in the US.
Position Overview:
We are seeking a Quality Assurance Validation (QAV) professional with expertise in supporting facility and equipment commissioning/qualification activities and managing facility control and equipment lifecycle programs. The role will involve ensuring compliance and operational excellence for a newly acquired 7-story facility in Boston, which will require extensive build-out over the next three years.
Key Responsibilities:
- Serve as a quality professional supporting facilities-related activities within a compliance-driven role.
- Collaborate with the commissioning and validation teams to review, analyze, and ensure the accuracy of associated documents.
- Perform document reviews and resolve deviations to maintain compliance with quality protocols.
- Ensure adherence to compliance standards, including validation protocols and regulatory requirements.
- Provide support for facility commissioning, validation, and lifecycle management activities.
- Oversee and support operations involving Biologics, with a focus on isolators, biosafety protocols, and bioreactors.
- Contribute to the development of teams and processes as the new facility is built out.
Required Qualifications:
- Experience: Minimum 6 years of quality assurance experience in the U.S., with a focus on facility commissioning and validation.
- Industry Expertise: Strong background in biologics, isolators, biosafety protocols, and bioreactors.
- Compliance: Solid understanding and hands-on experience with compliance protocols related to validation activities.
- Technical Skills: Ability to review and analyze technical documents, resolve deviations, and ensure documentation accuracy.
Preferred Qualifications:
- Familiarity with isolators is a significant plus.
- Demonstrated ability to support large-scale facility projects within a quality role.
