Senior Quality Specialist

CAI

23h•$80,000 - $95,000

About The Position

Quality Specialists plays a critical role in ensuring that products, services, and processes meet internal and external standards and requirements. The Quality Specialist 2 supports quality initiatives by managing audits and suppliers, analyzing quality data, managing client complaints, internal deviations, and CAPAs, overseeing the document and change management processes, participating in root cause analysis, and collaborating cross-functionally to drive continuous improvement across the organization. The ideal candidate brings a solid foundation in quality operations and is ready to take ownership of key processes, contribute to cross-functional initiatives, and drive continuous improvement.

Requirements

Bachelorâs degree in Life Sciences, Engineering, Quality, or a related field.
2-5 years of experience in Quality Assurance, Quality Control, or Quality Systems (regulated industry or professional services preferred).
Demonstrated experience in at least two of the following areas:
Complaint and/or Deviation
CAPA
Document control
Audits
Change Management
Supplier Management

Responsibilities

Maintain and enforce company quality systems in accordance with applicable standards (e.g., ISO 9001, GxP)
Ensure compliance with internal procedures, customer requirements, and regulatory guidelines.
Compile quality system data for presentation in Management Review
Participate in internal and external audits and support audit readiness efforts.
Coordinate and provide oversight to the supplier management process.
Promote a culture of continuous improvement, accountability, and operational excellence.
Own the document control process and assist in the creation, review, revision, and approval of standard operating procedures.
Support change management processes, ensuring proper documentation and validation activities.
Manage the end-to-end process for addressing complaints, deviations, and CAPAs.
Lead or support the investigation and documentation of complaints and deviations including root cause analysis and identification of CAPA.
Ensure all complaint and deviation records are accurate, complete, and compliant with applicable regulatory and quality standards.
Monitor complaint and deviation trends and provide regular reports to management with recommendations for improvement.
Track and verify the effectiveness of implemented CAPAs.
Develop and/or deliver training materials on quality-related policies, procedures, and processes
Serve as a resource for teams on quality standards and best practices.
Coordinate with the Learning and Development team to ensure development and assignment of quality-related training.
Analyze quality metrics, prepare trend reports, and suggest opportunities to optimize processes and reduce quality risks.
Collaborate with cross-functional teams to implement process improvements and quality initiatives.