Job Summary
The Quality Assurance Specialist 2 plays a crucial role in supporting contract testing services by ensuring adherence to current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) regulatory standards. This position is essential for maintaining high-quality standards and regulatory compliance in the organization.
Responsibilities
- Review controlled quality documents to ensure accuracy and compliance.
- Oversee and manage investigations related to quality issues.
- Engage in both internal and external audits to assess compliance and quality standards.
Qualifications
- Bachelor’s degree with a minimum of 2 years of experience in a relevant field, or
- Associate’s degree accompanied by 4 years of experience, or
- A High School diploma with 6 years of relevant experience in a science or GxP environment.
- Demonstrated proficiency in FDA and EU regulatory requirements.
- Strong communication skills to effectively convey information and collaborate with team members.
