Quality Assurance Specialist

Role Summary

Quality Assurance Specialist based in Framingham, MA. You will ensure GMP compliance, conduct audits, and lead quality investigations to maintain product quality throughout the lifecycle.

• Ensuring that activities in his/her scope are conducted in compliance with applicable regulatory requirements
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Conducting regular audits of production processes to identify and address potential quality issues
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
• Managing and resolving quality-related issues in a timely and effective manner
• Monitoring and analyzing quality performance metrics, implementing corrective actions as needed
• Leading root cause analysis investigations for quality incidents and implementing preventive measures
• Participating in internal and external audits and regulatory inspections providing support and documentation
• Developing and implementing risk management strategies to mitigate potential quality issues
• Fostering a culture of quality and continuous improvement across the organization

• Requested: BS – Life Sciences or related discipline; minimum of 2 years of experience in quality assurance within the pharmaceutical industry; strong knowledge of GMP
• Preferred: additional degree or certifications in related fields; broader QA experience or specialized training

• Ability to analyze complex data and identify trends, issues, and solutions
• High level of accuracy and attention to detail in all quality assurance activities
• Strong verbal and written communication skills for effective interaction with team members and regulatory bodies
• Proficiency in identifying problems and implementing effective corrective actions
• Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

• BS – Life Sciences or related discipline (preferred)