NJK & Associates, Inc.
Helping you jump your highest regulatory hurdles
If your organization is contemplating hiring a full-time QA/RA professional, you face a dilemma: (1) hire a more seasoned QA/RA professional who will be underutilized for much of his/her time, or (2) hire a more junior QA/RA professional that is not experienced in creating and operating a quality system and doing regulatory submissions. Of course you could contemplate hiring a seasoned QA professional AND a seasoned RA professional but then the costs go sky high and they are both underutilized.
Hiring overqualified staff is expensive and more often than not leads to them leaving after a short time. Seasoned professionals like to be challenged, and generally dislike not being used to their potential.
On the other hand, hiring junior personnel saves money. But their lack of experience can lead to implementation of overly complex systems and ultimately to quality and regulatory issues that cost time and money to fix, all the while damaging your company's good name.
Another challenge is that the hiring manager is often inexperienced in QA/RA and so does not know how to choose the best person at any level of accomplishment.
These are just some of the reasons why it often makes sense for small and mid-sized companies to consider engaging the services of professional QA/RA consultants. A good consultancy can act as your outsourced QA/RA department, and can help with the transition to full time employees as the need arises.
NJK & Associates, Inc. was founded by Natalie J. Kennel, RAC, ASQ CQE & CQMgr who serves as its president. Prior to her consulting career she worked for companies designing and manufacturing IVDs, surgical devices, and infusion pumps. Natalie has held a variety of roles in quality, regulatory, development, and manufacturing in both large and small companies. Natalie is expert in the development of new quality systems, software validation, and companies with regulatory agency "issues".
Every so often in life one comes across truly exceptional people and businesses. When that happens to us we strive to form lasting relationships. When those individuals and companies happen to have talents that can benefit our clients we play matchmaker in order to collectively provide services that delight our clients.
Our logo suggests that we are interested in horses, and jumping in particular. That would certainly describe one of our passions when not working. It also describes what we think differentiates us from others in the field, namely we take an active role in helping our clients to succeed. It is not within our personalities to merely suggest solutions, we make them happen by getting our fingers dirty alongside your employees.
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