Quality Assurance Specialist - Drug Product

Sanofi • Northborough, MA

96d • $74,250 - $123,750

About The Position

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? This position is onsite Monday-Friday, 1st shift - required.

Requirements

• Bachelor's degree in engineering or related field - preferred.
• 2+ years of experience in quality assurance within the pharmaceutical industry - required.
• Strong knowledge of Good Manufacturing Practices (GMP) and quality assurance principles - required.
• A combination of education and experience will be considered.

Nice To Haves

• 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

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

Benefits

• High-quality healthcare
• Prevention and wellness programs
• At least 14 weeks’ gender-neutral parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees