Quality Assurance Specialist
6 days ago
**Job Overview**
MILLENNIUMSOFT is seeking a highly skilled Quality Assurance Specialist to join our team. In this role, you will be responsible for reviewing and assessing quality notifications, complaints, deviations/waivers, and other cGMP activities for assigned product lines in the instrument plant.
Key Responsibilities:
- Oversee operations and ensure documentation and procedures are followed, updated, and maintained as required by internal quality policies and related FDA/GMP guidelines.
- Conduct complaint investigations and assist in the investigation of manufacturing issues.
- Provide data and input on technical issues and projects.
- Develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.
- Use Microsoft programs and ability to learn other systems.
Requirements:
- BS or BA in related field with 4 years of experience, or MS with 3 years of experience required (project management experience preferred).
- Typical degree in Mechanical or Electrical or Industrial Engineering, Biological Sciences, Chemistry, and/or Computer Science or other related field.
- Demonstrate a working understanding of pertinent quality systems regulations (i.e., Good Manufacturing Practices, ISO, FDA).
Estimated Salary:** $85,000 - $110,000 per year, depending on qualifications and experience. Benefits include health insurance, retirement plan, and paid time off.
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