Quality Assurance Auditor

Lori Spatola
[title]

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.

Bachelors of Science Degree Biology Edgewood College, 2004

Biotechnology Education

Biotechnology Program: 
Madison Area Technical College
Degree or certificate: 
Biotechnology Associates degree

Employer information

PPD, Inc.

Middleton, WI

What does this job involve?

Job Description and Responsibilities: 

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)

Commonly Used Skills and Techniques: 

his 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.

Rewards and Challenges

What do you find most rewarding about this job?: 

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.

What is the most challenging part of your job?: 

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

Other thoughts: 

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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