Quality Assurance Validation Specialist
2 weeks ago
Quality Assurance Validation Specialist (Contract)
Role Overview
SciPro is seeking a skilled Quality Assurance Validation Specialist to enhance our team on a temporary, onsite basis. In this pivotal role, you will report directly to the Quality Engineering Manager and be instrumental in supporting our quality assurance initiatives through documentation and validation activities related to automation projects. Your key responsibilities will encompass drafting design specifications, executing validation testing, and collaborating with both internal teams and external partners to ensure the successful execution of projects.
Key Responsibilities
- Prepare and review essential documentation, including user requirements, design specifications, and testing protocols.
- Conduct hands-on validation activities for automation projects, addressing any discrepancies in protocols.
- Work in conjunction with internal teams and external partners to establish timelines and coordinate validation efforts.
- Engage in project meetings and provide timely status updates to relevant stakeholders.
- Oversee project tasks and escalate issues to leadership as needed.
Qualifications
Applicants should possess a Bachelor's Degree and have a minimum of 5 years of experience in Quality and/or Manufacturing within the pharmaceutical, biotechnology, biologics, or cell therapy sectors.
A robust understanding of equipment and computerized systems is essential, along with knowledge of data integrity and change control management.
Exceptional interpersonal and technical writing skills are required.
Preferred qualifications include experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems.
Proficiency in Microsoft Office applications, including PowerPoint, MS Project, Excel, and Word, is necessary.
The ability to collaborate effectively across departments and with external partners is crucial.
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