Senior Quality Specialist

CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field tested processes, and elite expertise developed over 30 years. 

Our approach is simple because our Purpose informs everything we do: 

·       We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. 

At CAI, we are committed to living our Foundational Principles, both professionally and personally:  

·       We act with integrity  

·       We serve each other  

·       We serve society  

·       We work for our future  

At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing

expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done. 

Job Summary:

Quality Specialists plays a critical role in ensuring that products, services, and processes meet internal and external standards and requirements.  The Senior Quality Specialist 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.

Key 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.

- Bachelor’s 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

We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.

 

This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).