Quality Assurance Specialist

4 weeks ago


Boston, Massachusetts, United States Spark Life Solutions, Inc. Full time
Quality Assurance Validation Role

At Spark Life Solutions, Inc., we are seeking a highly skilled Quality Assurance Validation professional to support the commissioning, qualification, and validation of facility equipment and control systems. The ideal candidate will have strong experience in facilities quality assurance, especially within biologics or biotech environments.

Key Responsibilities:

* Review and approve all associated documents, ensuring accuracy and compliance with validation protocols.
* Identify and resolve deviations in facility and equipment qualification documents.
* Collaborate with the commissioning and validation teams to ensure all documentation aligns with quality standards.
* Develop and execute quality protocols to ensure smooth facility build-out over the next 3 years.

Requirements:

* Solid background in compliance, with a focus on validation protocols and facility qualification.
* Proven experience with biologics manufacturing processes, including the use of isolators, bioreactors, and biosafety equipment.
* Excellent communication and teamwork skills to work cross-functionally within validation and commissioning teams.

If you are a motivated and detail-oriented professional with a passion for quality assurance, we encourage you to apply for this exciting opportunity.

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