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.
The businesses of Merck KGaA, Darmstadt, Germany provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
