Quality Specialist

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud – the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions. 

OVERVIEW

As the Quality and Training Specialist, you will provide support across the Quality and Compliance function including but not limited to conducting Internal Audits per Audit Plan, supporting Client Audits, helping to maintain the company Quality Management System (QMS), own QMS Training and administration, as well as providing general Quality support for the organization as required. 

KEY TASKS & RESPONSIBILITIES

• Support team efforts around Audits (Client, Vendor and Internal)
• Serve as the lead in scheduling all client audit request and being the logistical point of contact which will include facilitating follow-up and audit responses seeing the process to closure
• Support the audit or inspection of any vendors or partner organizations relative to their creation of computer system products, use of computerized systems, or quality systems software, as assigned by management
• Provide a supporting role during Client audits and / or related inspections
• Work collaboratively across various functional organizations including India Operations
• Serve as a key owner of the QMS Training Program, including administering assignments and upkeep of Training Matrix
• Supports quality metric compilation, analysis, trending, and reporting.

CANDIDATE’S PROFILE

Education & Experience

• BS degree or job-related equivalency
• 3 years of experience Quality, Compliance or similar administrative role working in a fast-paced working environment preferred

Professional Skills:

• Excellent knowledge of English
• Strong understanding of business goals and standards for customer service
• Strong Presentation/Public Speaking skills
• Excellent decision-making skills
• Strong interpersonal and communication skills
• Team player and Collaborator that can handle multiple tasks simultaneously in a fast-growing company.

Technical Skills:

• Strong time-management and organizational skills
• Problem-solving skills
• Critical-thinking skills
• Adaptable to change
• Attention to detail

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: https://topworkplaces.com/company/eclinical-solutions/

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.