Position: QA Engineer
Location: Austin, Texas, United States
Department: Pharmaceutical Manufacturing
Employment Type: Full-time
Job Summary:
We are seeking a detail-oriented and proactive QA Engineer to join our pharmaceutical manufacturing team in Austin, Texas. The QA Engineer will play a critical role in ensuring that all manufacturing processes, products, and systems meet regulatory compliance standards and quality specifications.
Key Responsibilities:
- Develop, implement, and maintain quality assurance protocols and procedures in accordance with FDA and other regulatory guidelines.
- Perform routine inspections, audits, and quality checks of manufacturing processes and products.
- Collaborate with cross-functional teams including production, R&D, and regulatory affairs to resolve quality issues.
- Document and report non-conformances, deviations, and corrective actions.
- Support validation and qualification activities for manufacturing equipment and processes.
- Contribute to continuous improvement initiatives to enhance product quality and manufacturing efficiency.
Qualifications:
- Bachelor’s degree in Life Sciences, Engineering, or related field.
- Proven experience in quality assurance within pharmaceutical manufacturing or regulated environments.
- Strong knowledge of Good Manufacturing Practices (GMP), FDA regulations, and quality management systems.
- Excellent analytical and problem-solving skills with high attention to detail.
- Effective communication and teamwork abilities.
Join us and contribute to the delivery of high-quality pharmaceutical products that comply with stringent industry standards, ensuring patient safety and product efficacy.