Quality Specialist

Lumanity is dedicated to improving patient health by accelerating and optimizing access to medical advances. We partner with life sciences companies around the world to generate evidence to demonstrate the value of their product, translate the science and data into compelling product narratives, and enable commercial decisions that position these products for success in the market. We do this through strategic and complimentary areas of focus: Asset Optimization and Commercialization, Value Access and Outcomes, Medical Strategy and Communications, and Real World Evidence.

The Quality Specialist is responsible for ensuring that our clients’ businesses are in compliance with Good Manufacturing Practices (GMPs) and applicable regulations. As Quality Specialist, you are expected to be well versed in the processes adhered to by consumer healthcare businesses to maintain regulatory compliance. You must put a high value on effectively communicating compliance policies and processes as well as recommendations and solutions to quality problems to people in both business roles and in quality roles.

Key responsibilities include:

• Write and/or revise Standard Operating Procedures (SOPs) as required by clients
• Lead investigations into consumer complaints and make recommendations for product improvements.
• Review and approve investigations and change management documents, as required by the clients, on their behalf.
• Review and release products for commercial distribution.
• Coordinate stability and other quality testing programs
• Address and escalate (if needed) quality issues that arise
• Perform Quality Audits of manufacturing facilities, (in person, virtual, hybrid) if required
• Develop and implement Corrective/Preventive Actions (CAPA)
• Other quality related projects as required by clients

The ideal candidate is inquisitive, ambitious, hardworking and has a strong interest in the healthcare field, including the following characteristics:

• Bachelor's degree in a life science or related field
• Minimum 5 years’ experience in quality assurance and/or quality compliance.
• Preferred certification in Quality (i.e., Certified Quality Auditor, Certified Quality Engineer, etc.)
• A background in Good Manufacturing Practices for drugs, dietary supplements and/or medical devices
• Proficient with Word, Outlook, Excel, and PowerPoint
• Eagerness to work independently and in teams in a fast-paced environment.
• Experience reviewing and interpreting scientific data and developing practical solutions to quality related issues.
• Ability to leverage resources and continually learn and expand knowledge base
• Passion for helping clients maintain regulatory compliance and delivering actionable solutions to quality problems.

We offer our employees a comprehensive benefits package that focuses on what matters to you – health and well-being, personal finances, professional development, and a healthy work/life balance:

• Competitive salary plus bonus scheme
• Medical, dental, and vision insurance options
• 401(k) plan with employer match
• Generous amount of paid time off annually + 10 paid holidays
• Employee Assistance Program
• Company-paid short-term and long-term disability coverage
• Flexible spending accounts for health and dependent care

Employees can expect to be paid a salary between $100,000-$130,000. The salary range is merely an estimate and may vary based on an applicant’s location, skills, prior experience, professional qualifications, and other relevant factors.

#LI-Hybrid