Quality Assurance Specialist

7 days ago


Madison, Wisconsin, United States Germer International Full time

About the Role:

We are seeking a highly skilled Quality Assurance Specialist - Pharmaceutical Manufacturing to join our team at Germer International. The successful candidate will be responsible for ensuring the highest standards of quality in our pharmaceutical manufacturing environment.

Key Responsibilities:

Prepare and execute validation protocols for cGMP processes, production/laboratory equipment, cleaning procedures, and software in compliance with Q7.
Assist with and write final reports for executed validation protocols.
Provide technical assistance to other Validation staff and all other departments regarding validation issues.
Write and/or revise department and company SOPs.
Serve as Validation representative for cross-functional projects.
Participate in external audits (customer, FDA, etc.).

Requirements:

Bachelor's Degree or above in Chemistry, Biological Sciences or Engineering (Chemical, Electrical, Mechanical, Reliability) or related discipline.
2+ years of related pharmaceutical CDMO experience.



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