Senior Quality Specialist - #2170224

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

Responsible for managing active and completed studies archives and maintaining QMS logs and records and assisting the Director of Quality Assurance in monitoring regulatory compliance and quality in clinical trial operational activities.

Essential Duties And Responsibilities

• Contribute to the implementation, maintenance, continuous improvement, and advancement of GxP-compliant Quality Management Systems (QMS), ensuring alignment with both local and global regulatory requirements.
• Coordinate and host external audits and assessments at LabConnect facilities in Germany and the Netherlands, ensuring readiness and compliance with GxP and ICH-GCP standards.
• Support the management of clinical trial documentation, assisting the Document Retention Administrator with the archival and retrieval of ICH E6-regulated documents. Act as a liaison with clients and stakeholders to coordinate document transfers and ensure timely access to archived materials.
• Conduct internal audits and ensure effective follow-up and closure of corrective actions.
• Assist in the investigation of quality events, deviations, and non-conformances, contributing to root cause analysis (e.g., 5 Whys, Ishikawa) and implementation of corrective and preventive actions (CAPAs).
• Perform supplier qualification and re-evaluation activities, both onsite and remotely, using the global electronic Quality Management System (eQMS), ensuring vendor compliance with LabConnect quality standards.
• Review Change Control documentation, providing guidance operational teams on regulatory compliance and quality-related matters.
• Support software validation efforts related to clinical trial systems, ensuring validation activities meet regulatory expectations and internal quality standards.
• Collaborate cross-functionally with internal departments to address client quality-related requests and ensure alignment with clinical trial protocols and regulatory expectations.
• Perform additional quality-related tasks as assigned, contributing to the overall effectiveness of the Quality Assurance department at LabConnect.
  
  

Education/Experience

• 4 -year degree preferred with Quality Assurance Experience; or a 2-year degree with more than 3 years related experience and/or training; or equivalent combination of education and experience. Must possess strong organizational and interpersonal skills as well as, office or administrative experience.
• Must possess excellent organization and interpersonal skills.
• Customer service experience desired.
  
  

Certificates and Licenses

N/A

Language Ability

Ability to read, analyze, understand and speak in English. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format.

Any other language is valuable.

Reasoning Ability

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Computer Skills

To perform this job successfully, an individual should have knowledge of Microsoft Office applications, word processing software, powerpoint; spreadsheet software and basic knowledge of database structure.

Read more below and get ready for your next great employment adventure!

Some of the Perks our LabConnectors Love:

• We truly live our values: People First, Quality Focused, Customer Centered, Technology Driven and Accountability Always.
• The ability to make an impact on a passionate and growing team
• Great communication on a smaller sized team
• A market based salary
• Tools to effectively do your job (laptop, phone reimbursement)
  
  

In addition to great perks and challenging work assignments, we invest in our people with enriching career growth opportunities. We believe in a friendly and collaborative environment with open lines of communication. Join our team and discover how your work can impact the lives of people all over the world.

It is the policy of LabConnect to provide equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information, or any other protected characteristic under applicable law.

Equal Employment Opportunity Posters:

https://www.dol.gov/agencies/ofccp/posters

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email [email protected] or call +1(423)722-3155.

For more information, visit www.labconnect.com