Job Summary
The Quality Assurance Specialist plays a critical role in upholding quality systems by conducting an analysis of batch records, examining raw materials, and providing oversight for quality assurance during Good Manufacturing Practice (GMP) operations in the biotechnology and pharmaceutical sectors.
Responsibilities
- Review batch records to ensure compliance with established quality standards.
- Inspect raw materials for conformity to regulated specifications.
- Provide oversight during GMP manufacturing processes to maintain quality assurance.
- Facilitate investigations into quality issues and non-conformities.
- Manage Corrective and Preventive Action (CAPA) programs effectively.
- Ensure adherence to standard operating procedures throughout the manufacturing process.
Qualifications
- Bachelor’s degree in a life science discipline is required.
- 6-10 years of relevant experience in Quality Assurance within GMP manufacturing.
- Background in the biotechnology or pharmaceutical industries is preferred.
- Deep understanding of current Good Manufacturing Practices (cGMPs).
- Exceptional communication abilities, both written and verbal.
Miltenyi Biomedicine 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.
