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.

Responsibilities

• 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

Qualifications

• 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

Skills

• 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

Education

• BS – Life Sciences or related discipline (preferred)