Senior Quality Specialist

Senior Quality Specialist

Overview LabConnect improves lives by partnering with pharmaceutical and biotech companies, and clinical research organizations (CROs) to accelerate the development of new medicines around the world. We are an independent, global, one-stop-shop focused on delivering Central Laboratory Services that are tailor-made, timely and flexible to meet the evolving study demands of traditional to increasingly complex trials. Additionally, we provide Functional Service Provider (FSP) Solutions, supporting our clients with scientific and technical expertise, acting as an extension of their team, coordinating all laboratory related needs, advising on strategies for lab data collection and providing end-to-end analytical and logistical solutions.

The Senior Quality Specialist is responsible for assisting Quality Leadership with ensuring compliance and quality processes are maintained in support of clinical trial operational activities. The Senior Quality Specialist will serve as chief administrator for the quality management software (QMS) and is responsible for development, configuration and management of the QMS.

Essential Duties and Responsibilities

• Leads and project manages QMS activities including document control, change control, non-conformance reporting and supplier qualification/requalification
• Serves as team lead CSV specialist
• Responsible for data reduction, metrics and managerial reports delivery
• Supervise and assist in management of QMS Non-Conformance reporting and their related investigation, root cause analysis, proposed corrective and/or preventive measures, and due diligence thereto
• Trains QMS users on workflow and associated tasks for modules within the QMS
• Leads eQMS configuration and improvement specialist
• Assesses, creates, and presents QMS Lean and Process Efficiency opportunities and projects
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses
• Provide industry leading QMS compliance guidance and quality assurance consultation to internal and external stakeholders
• Clear and concise communication of QMS reporting for regulatory and quality consulting advisements
• Schedules and conducts monthly quality review meetings as required
• Prepare training materials and conduct training for QMS topics
• Collaborates with Human Resources regarding training program requirements affected by the QMS
• Serves as Quality subject matter expert for configurable systems validation projects
• Conducts research, and compiles and types statistical reports
• Performs other tasks as defined by the Quality Assurance Leadership

Education and Experience

• 4 -year degree preferred with 5-7 years of Quality Assurance Experience; or a 2-year degree with 8-10 years related experience and/or training; or equivalent combination of education and experience.
• Veeva Belt certification preferred.

Skills and Ability

• Must possess strong organizational and interpersonal skills.
• Experience with QMS platforms such as Veeva is highly preferred.
• Proven track record of leading QMS implementations or enhancements is a strong asset.

Supervisory Responsibilities: None

Physical Demands:

While performing the duties of this job, the occupant is regularly required to:

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.

Travel Requirements: Minimal

Join our team and discover how your work can impact patients' lives around the world!

Some of the Perks our LabConnectors Love:

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!

In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.

We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic.