GxPNinja is your partner for software development, validation, and project management. Including serving FDA regulated industries.
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GxP
represents a set of multiple “Good” “Practices” standards. Such as Good Laboratory Practices and Good Manufacturing Practices. They are drivers for the development and validation of software used by pharmaceutical and medical device manufacturers.
Ninja
is a society begun over 800 years ago in the mountains of Japan. The members were agents with specialized skills and training, and were hired for covert operations.
Ninja is also a brand of sport motorcycle. It is known for agility in handling the unexpected, speed to the finish line, and ultimate customer satisfaction!
GxP Ninja
is an association of consultants with over 15 years experience working in the full product / software development life cycle. As well as the supporting systems covered by CSV (computerized systems validation). Flexible work arrangements can include on-site, off site, remote, or a blend. Flexible contract arrangements may include fixed bid, hourly, 1099, or W2.
Locations
We are located in Orange County, CA, U.S.A. and are local to Aliso Viejo, Anaheim, Brea, Buena Park, Costa Mesa, Cypress, Dana Point, Fountain Valley, Fullerton, Garden Grove, Huntington Beach, Irvine, La Habra, La Palma, Laguna Beach, Laguna Hills, Laguna Niguel, Laguna Woods, Lake Forest, Los Alamitos, Mission Viejo, Newport Beach, Orange, Placentia, Rancho Santa Margarita, San Clemente, San Juan Capistrano, Santa Ana, Seal Beach, Stanton, Tustin, Villa Park, Westminster, Yorba Linda. Also metropolitan Los Angeles and San Diego. Travel arrangements can be made and for example have included Illinois, Minnesota, Puerto Rico, San Francisco, Virginia, Washington, and more.
Our Team
Full time or part time, limited duration or long term, workforce augmentation or consulting, our services have benefitted start ups to the Fortune 500.
Our principals are STEM (Science, Technology, Engineering, and Math) degreed professionals in technology areas including Electrical Engineering, or Information Technology, with also some advanced Technology or Business degrees.
We maintain credentials and actively volunteer in our industry associations. Including training or certifications from ASQ (American Society for Quality), and PMI (Project Management Institute). Also continuing education through college course work, Webinars, and work shops.