Quality Associate, Quality Processes

Job not on LinkedIn

🔥 0 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

ERGOMED

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ERGOMED is a global group providing specialized services to the biotechnology and pharmaceutical industries. It operates under different service lines, including Ergomed Clinical Research, PrimeVigilance, and ADAMAS Consulting, and is dedicated to providing full-service clinical research organization (CRO) capabilities. Focused on oncology, rare diseases, and complex trials, it also offers end-to-end pharmacovigilance and medical information services, as well as comprehensive GxP audits. Ergomed is committed to supporting drug development with a global presence in around 100 countries.

📋 Description

• Support colleagues and functional teams in developing, managing, and implementing Controlled Procedures • Support GxP activities to ensure compliance with applicable legislation, guidelines, and standards, including ICH, CIOMS, and ISO • Provide guidance on procedures and requirements related to GxP Quality Operations and Training • Support GxP training activities across the Ergomed group • Track training activities through completion • Partner with Learning and Development to develop effective training • Assist in triage and management of access to the Ergomed Group Quality Management System • Participate in efficiency projects to enhance use and management of the Quality Management System • Manage access requests to Controlled Systems for employees and clients • Assist in Business Continuity activities across the Ergomed Group • Support functional and Quality teams during audits and inspections by supplying reports or procedures • Prepare and analyze Quality Operations and Training metrics and provide periodic reports to management • Assist in preparing CAPA or Deviation records resulting from issues in Controlled Document, GxP Training, or BCP processes • Foster a collaborative, high-performing quality culture across global teams and regions • Provide coaching and professional development opportunities to enhance team capability and succession planning

🎯 Requirements

• University degree in Biomedical Sciences, Natural Sciences, or Health Sciences required • Nursing, Pharmacy, or BS/Master’s degree in a scientific discipline, or suitable experience • Knowledge of applicable GxP legislation, guidelines, and standards, including ICH, CIOMS, and ISO • Ability to support Controlled Procedures and Quality Management System processes • Ability to support GxP training activities and track completion • Ability to assist with Business Continuity activities, audits, and inspections • Ability to prepare and analyze quality metrics and periodic management reports • Ability to prepare CAPA or Deviation records • Ability to provide coaching and professional development support

🏖️ Benefits

• Remote work • Work-life balance • Collaborative international team • Career growth opportunities • Professional development opportunities • Coaching and professional development opportunities