CAI is a 100% employee-owned company established in 1996, that has grown year over year to almost 500 people worldwide. We provide commissioning, qualification, validation, start-up, project management and other consulting services to FDA regulated and other mission critical industries.
CAI are seeking motivated Quality Assurance (QA) Validation Associate to support biotech and pharmaceutical projects across the country. These are full-time opportunities with 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.
As consultants to the entire industry, our employee owners are driven by the challenge and constant diversity of assignments, while having the stability of a company that has never had a lay off.
On any given day we could be responsible for a myriad of things involved in starting a facility, equipment or process up including protocol writing and execution, FAT's SAT's, walk downs and development of summary reports at the client site.
To get to those diverse projects our people can experience heavy travel. Although some people rarely travel, it is the exception to the rule. It’s not unusual for our employee owners to travel locally M-F to client sites. If the distance is greater, or spans more time zones, we sometimes travel to the site for 10 days then come back for 4. We don’t want to spend our free time in airports or doing laundry to pack again, and we don’t expect our employees to.
The QA Validation Associate 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.
Requirements include: BS in a science or equivalent discipline
Proven track record in Quality and Compliance.
Professional Quality Assurance Accreditation desirable
Demonstrated Continual Professional Development
3-5 years' experience within GMP regulated facilities
Experience with Aseptic manufacture desirable
Experience with Packaging processes desirable
Pharmaceutical Compounding experience desirable
Deviation and CAPA program experience
Remediation project management a plus
Experience with project management is a plus
Experience delivering efficient QA compliance solutions overseeing and reviewing the SDLC/CSV/Qualification activities.
Oversight of execution for Validations and Qualifications.
QA oversight of testing activities.
Reviews completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
Analyses the results of testing and determines the acceptability of results against pre-determined criteria.
Excellent oral and written communication skills in English
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 in the future.