QA Specialist

Raleigh, North Carolina  /  South Atlantic  /  Full Time

About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to nearly 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Please check CAI out on Glassdoor to get a better perspective on our culture. We are extremely proud that our employee owners and others have given us so many 5-star ratings.
Meeting a Higher Standard
Our approach is simple; we put the client’s interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of 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
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
With employee ownership, one person’s success is everyone’s success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a Can-Do Attitude (our core values). That is how we have grown exponentially.
Employment Benefits
Our full-time positions offer competitive compensation and benefits which include up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
The QA Specialist will be exposed to cutting edge technologies in the advanced medicine space. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing lifesaving therapies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Requirements include
Position Description: We are now seeking a Quality Specialist to join our growing operations in North America. The QA Specialist will be responsible for the following:
Provide knowledge and experience in Quality Systems and/or Operational Quality such as the following i.e., Deviation/ Change Control /Laboratory Investigations/Environmental Monitoring.
Perform Batch Disposition preparation, Batch record review, Certification process oversight.
Strong cGMP and regulatory requirement understanding.
Experience in SAP release, SAP deviation system and Trackwise.
Support all quality and compliance requirements for and leading to commercial manufacturing.
Uses knowledge to improve Quality Systems and/or Operational Quality with clients; solve complex problems and provide guidance and support for continuous improvement.  
Understand and apply regulatory / compliance requirements to the role ensuring alignment and recommendation with current or upcoming regulatory and compliance changes.
Interpret client’s needs, assesses requirements, and identifies solutions to non-standard requests.
Position Requirements:
BS or MS in a relevant science or engineering field, or equivalent
Proven track record in Quality and Compliance.
Professional Quality Assurance Accreditation desirable
3-5 years' experience within GMP regulated facilities
Experience with Aseptic manufacture desirable
Experience of batch record review and product release essential
Excellent oral and written communication skills in English
Ensure the highest Quality, Compliance and Safety standards
Works collaboratively to facilitate client and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture 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.
Other Requirements:
Excellent oral and written English is required
Able to travel domestically and internationally if required 
Able to work (paid) overtime 
Able to work in the US without sponsorship now or any time or in the future



(Varies by Country, Below is a General Overview)

  • 100% Employee Owned
  • 24 Days PTO/5 Sick days per year + Additional Holidays depending on Country
  • Medical / Dental / Vision (In accordance with each countries’ applicable regulations)
  • Professional Development (Approximately $5,000 paid career-related, continuing education)
  • ESOP/401k – 15% Company Contribution
  • Company Paid Long-Term Disability
  • Company Paid Life Insurance
  • Company Paid Parental Leave (In accordance with each countries’ applicable regulations)
  • Other Benefits Depending on Country