CAPA Specialist - Quality & Regulatory Systems

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. 

Summary 
The CAPA Specialist (Corrective and Preventative Action) is responsible for assisting the Sr. Manager Quality Control, functional Quality Event Subject Matter Experts, and operational leaders in Quality Event (QE) manage tasks, investigations and actions assuring on-time and accurate closure of records and provision to clients. The CAPA Specialist will frequently interact with cross functional groups and internal and external partners to ensure compliance initiatives are met. 

Responsibilities

• Schedules and organizes internal triage, risk and impact assessment meetings for potential quality event management.
• Schedules and conducts team meetings supporting quality event actions, including but not limited to, investigations, root cause analysis, corrective actions, preventive measure
• Schedules and performs effectiveness verifications of closed preventive measures to assure effectiveness of change management events
• Updates and maintains QRS Key Performance Indicators and other metrics as necessary for assuring timely decision making and updating management.
• Assists Sr, Manager, Quality Control with identifying areas of risk and opportunity for continuous improvement initiatives
• Assists Project Managers and operational management with quality and regulatory advice and assistance when required.
• Tracks, trends and monitors actions pertaining to non-conformance reporting or document change control.
• Composes timely routine correspondence to internal and external stakeholders.
• Organizes and maintains electronic and hard-copy file system, and files records as appropriate.
• Independently conducts research, and compiles and types statistical reports.
• Coordinates and arranges meetings, prepares agendas, reserves and prepares facilities, and records and transcribes minutes of meetings.
• Performs frequent assessments of quality system for continuous improvement initiatives.
• Trains new hires on job specific duties as deemed appropriate.
• Acts as QRS representative in internal and external meetings with key stakeholders and/or Clients.
• Performs other related duties and tasks as necessary or as assigned by Quality Management. 

Education/Experience/Skills Required:

• Bachelor’s degree (B.S./B.A.) preferred
• At least two years of directly related experience, 4+ years preferred. 
• Excellent communication skills, both verbal and written. 
• Ability to work with cross functional team members to ensure that the process is being completed on time and compliance issues are met.
• Strong organizational skills with the ability to focus and to execute multiple projects and programs simultaneously while maintaining a high level of attention to detail. 
• Ability to work independently as well as part of a team.
• Proficient in MS Office Suite, including MS Word, MS Outlook, MS Excel, MS PowerPoint, Visio and MS Project.

Working Location:

• This is an in-office position, Monday - Friday, standard business hours.