What are the responsibilities and job description for the Quality Assurance Validation position at Katalyst HealthCares & Life Sciences?
Position Overview:
We are seeking an experienced Quality Professional with a strong background in facilities and equipment commissioning/qualification within the biologics industry. This individual will support the commissioning and validation of a new seven-story facility in Boston, ensuring compliance with regulatory requirements and internal quality standards. The role involves reviewing and managing documentation, sorting out deviations, and ensuring accuracy in validation protocols.
- Commissioning & Qualification Support:
- Assist in facility and equipment commissioning and qualification activities.
- Ensure compliance with FDA, GMP, and industry regulations during facility build-out.
- Work closely with validation and engineering teams to review associated documents for accuracy.
- Identify, assess, and address deviations in validation documentation.
- Quality & Compliance:
- Review and approve validation protocols, reports, and related documentation.
- Ensure compliance with regulatory requirements for biologics manufacturing.
- Support facility control and equipment lifecycle programs.
- Collaborate with internal teams to maintain high standards of quality and compliance.
- Technical Expertise:
- Experience with isolators, biosafety cabinets, bioreactors, and other biologics-related equipment.
- Work with isolators for sterile and containment applications.
- Apply strong knowledge of GMP, validation, and facility compliance requirements.
- 8 years of experience in a quality role with a focus on facilities, commissioning, and validation.
- Strong background in compliance, validation, and quality systems within biologics manufacturing.
- Experience reviewing validation documents, identifying deviations, and ensuring accuracy.
- Knowledge of isolators, bioreactors, biosafety requirements, and related equipment.
- Familiarity with GMP, FDA regulations, and facility compliance standards.
- Ability to work cross-functionally with engineering, validation, and operations teams.
- Experience supporting large-scale facility build-outs within a quality role.
- Background in equipment lifecycle management and facility control programs.
- Strong communication and documentation review skills.
