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Quality Assurance Auditor



Lori Spatola

Lori Spatola
PPD, Inc.
Middleton, WI

Biotechnology Education:

Madison Area Technical College Associate Degree Biotechnology Laboratory Technician Bachelors of Science Degree Biology Edgewood College, 2004

Background:

After graduating from MATC, I worked at Agracetus for 8 years, working on the production of therapeutic proteins produced in plants. Through an articulation agreement between MATC and Edgewood College I obtained a Bachelor of Science degree while working.

Description of responsibilities:

PPD, Inc.

In my job I review testing results and documentation against the requirements of company and client SOP's. I need to be familiar with Federal regulations, both good manufacturing practices (cGMP), good laboratory practices (GLP)

Working conditions:

Hourly position, work 40 + hours per week

 

 

Physical skills needed:

My job includes a lot of computer work, report filing and desk-work. I am required to sit for long periods of time.

Personal skills needed:

This position requires the ability to problem solve and multi task. Good Information Technology skills and Investigative skills are essential. I am also required to have good interpersonal skills and the ability to communicate with all levels of employees within the company.

Position advantages:

My position is different from standard laboratory work. I work behind the scenes, making sure the essentials are fulfilled. I have flexibility in hours and no boundaries.

Position disadvantages:

I do miss hands-on laboratory work and some aspects of my job are repetitious.

Advice to anyone entering this field:

There is a lot of room for professional growth. People with regulatory affairs experience/quality assurance are highly sought after by pharmaceutical companies. Be prepared to continually learn new regulations, interpretations and guidelines.


 

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