Quality Specialist I - Quality & Regulatory Systems - #2118053

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

• Assists in scheduling and organizing internal and external assessments of LabConnect by QRS or Clients.
• Assists Document Retention Administrator with document retention and archival duties of Good Clinical Practices (ICH E6) regulated documents. Communicate directly with clients regarding the archived documents and coordinate the document deliveries from all stakeholders.
• Coordinate and assure document retrieval and management during regulatory and client audits as necessary
• Schedules and performs internal audits
• Performs remote assessments of LabConnect vendors on a risk-based schedule.
• Performs document control activities including formatting of documents, updating tables of contents, obtaining approval signatures, coordinating training on new and revised documents, logging and filing training sheets.
• Reviews IT change Control and advises IT and operations as needed regarding regulatory compliance or quality issues.
• Support the QRS department on software validation activities
• Communicate effectively with all internal partners regarding client requests
• Performs other related duties and tasks as necessary or as assigned.
  
  

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.

Supervisory Responsibilities

This position does not have any supervisory responsibilities.

This position requires a high level of independent work and autonomous decision making.

Work Environment

The noise level in the work environment is usually moderate.

Physical Demands

The employee must occasionally lift and/or move up to 20 kg. While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel and talk or hear. The employee is occasionally required to reach with hands and arms.

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