We are seeking QA Validation Specialists with 3-5 years' experience within GMP regulated facilities.
CAI is a 100% employee-owned company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services associated with operational readiness to FDA regulated and other mission-critical industries.
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.
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.
CAI agents 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.
The QA Validation Specialist at CAI will provide Quality and Compliance guidance to domestic and international clients. This person will have responsibilities encompassing Pharmaceutical Quality Systems, Quality Risk Management, Inspection readiness and GMP Compliance.
BS in an engineering, science, or equivalent discipline
3-5 years QA Validation experience within GMP regulated facilities
Proven track record in Quality and Compliance.
Oversight of execution for Validations and Qualifications.
Deviation and CAPA program experience
Reviews completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
QA oversight of testing activities.
Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
Demonstrated Continual Professional Development
Remediation project management a plus
Experience with project management is a plus
Professional Quality Assurance Accreditation desirable
Experience with Aseptic manufacture desirable
Experience with Packaging processes desirable
Pharmaceutical Compounding experience desirable
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future
Must have been vaccinated or willing to be vaccinated for COVID-19 prior to starting employment