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Quality
Assurance
Auditor

picture of Lori Spatola

Lori Spatola

Pharmaceutical Product Development
Middleton, Wisconsin
Biotechnology Education
Madison Area Technical College Associate Degree Biotechnology Laboratory Technician; Bachelor 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
Pharmaceutical Product Development (PPD)
In my job I review testing results and documentation against the requirements of company and client SOPs. 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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Contact Us:

Lisa Seidman
lseidman@matcmadison.edu
(608) 246-6204

Jeanette Mowery
jmowery@matcmadison.edu
(608) 243-4307

Updated: April 26, 2006

Maintained by Joan Millard