Ensuring the highest standards of quality is a critical component of our operations. As a Quality Compliance & Training Specialist, you will play a pivotal role in maintaining our facilities' adherence to Good Manufacturing Practice (GMP) regulations.
Responsibilities:
1. Work closely with our small molecule Active Pharmaceutical Ingredient (API) clinical manufacturing facility team to ensure seamless quality compliance and training activities.
2. Collaborate with cross-functional teams to identify areas for improvement and implement corrective actions as necessary.
3. Develop and deliver comprehensive training programs to enhance staff knowledge and skills in GMP compliance.
4. Maintain accurate records of quality control measures, inspections, and audit results.
5. Stay up-to-date with regulatory requirements and industry best practices to inform our quality management strategies.
This role presents an excellent opportunity to make a tangible impact on the quality of our products and contribute to our commitment to excellence.
Requirements:
* Bachelor's degree in a relevant field, such as Life Sciences or Regulatory Affairs.
* Minimum 3 years of experience in quality assurance, regulatory affairs, or a related field.
* Excellent analytical and problem-solving skills, with the ability to interpret complex data and develop actionable insights.
* Strong communication and interpersonal skills, with experience working collaboratively with cross-functional teams.
* Familiarity with GMP regulations and industry standards, with the ability to apply this knowledge in a real-world context.
We offer a competitive compensation package, comprehensive benefits, and opportunities for professional growth and development.