Quality Assurance Compliance Specialist

3 weeks ago


Grafton, Wisconsin, United States Apex Systems Full time
Job Description

We are seeking a highly skilled Quality Assurance Compliance Specialist to join our team at Apex Systems in the Milwaukee, WI area. The ideal candidate will have a strong background in cGMP FDA-regulated industries and excellent written/oral communication skills.

Responsibilities:
  • Maintain environmental monitoring database and compile trend reports.
  • Perform real-time batch record review to ensure executed records are 100% completed and ready for review.
  • Represent Curia Quality Assurance when managing issues requiring immediate corrective action.
  • Assist in performing investigations, internal audits, and weekly walkthroughs.
Requirements:
  • Ambitious Associate's degree in a related field or Bachelor's degree in a life science field.
  • At least 3-5 years of experience in a cGMP FDA-regulated industry.
  • Strong familiarity with 21CFR210 and 211 or 820 regulatory requirements.
Compensation and Benefits:

$65,000 - $80,000 per year, depending on qualifications and experience. Our comprehensive benefits package includes medical, dental, and vision insurance, 401(k) matching, and paid time off.



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