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Document Control and Training Coordination Specialist - Job Opportunity at ORGENTEC Diagnostika GmbH

Mainz, Germany
Full-time
Senior
Posted: February 28, 2025
On-site
EUR 55,000 - 70,000 annually based on location and industry standards in German pharmaceutical sector

Benefits

Comprehensive healthcare package including vision care and flu vaccinations
30% employer contribution to private pension
Subsidized canteen and free beverages
Childcare allowance up to 200€
Brand discounts program
Flexible working hours with work-life balance focus
Annual salary reviews
Professional development and training programs
Anniversary bonuses
On-site parking

Key Responsibilities

Lead implementation and optimization of document management systems with regulatory compliance focus
Develop and maintain standard operating procedures (SOPs) and conduct specialized staff training
Spearhead electronic document management system integration projects
Ensure quality management system adherence and continuous improvement
Represent organization in regulatory audits for document control systems
Design and oversee comprehensive training programs and needs assessments
Manage training matrix coordination with HR and department leadership
Direct role definition processes and onboarding system development

Requirements

Education

Master's degree in Natural Sciences, Engineering or Quality Management

Experience

Multiple years of QA experience in diagnostics, pharmaceutical or medical field

Required Skills

GMP-regulated environment experience Electronic document management system expertise Analytical and systematic work approach Advanced MS Office proficiency Fluent English communication skills Quality system knowledge Process management capabilities
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Sauge AI Market Intelligence

Industry Trends

The diagnostic and pharmaceutical industries are experiencing increased regulatory scrutiny, elevating the importance of robust document control systems Digital transformation in quality management systems is driving demand for specialists who can bridge traditional QA with modern electronic systems Growing focus on training documentation and compliance in regulated industries creates expanded responsibility scope for document control roles

Role Significance

Typically operates within a quality management team of 5-10 people, coordinating with multiple departments
Senior specialist position with significant influence on organizational compliance and operational efficiency

Key Projects

Electronic document management system implementation and optimization Regulatory audit preparation and management Training program development and standardization Quality system enhancement initiatives

Success Factors

Strong understanding of GMP regulations and quality management principles Ability to bridge technical documentation requirements with practical implementation Excellence in stakeholder management across departments Balance between systematic approach and adaptive problem-solving

Market Demand

High demand driven by increasing regulatory requirements and digital transformation initiatives in pharmaceutical and diagnostic industries

Important Skills

Critical Skills

GMP compliance expertise essential for maintaining regulatory standards Change management capabilities crucial for system implementation Strong communication skills necessary for cross-functional coordination

Beneficial Skills

Project management methodologies Risk assessment capabilities Industry-specific software knowledge Quality audit experience

Unique Aspects

Combined focus on document control and training coordination provides broader career development opportunity
Position in market-leading company offers exposure to best-in-class quality management practices
International company environment with strong growth trajectory

Career Growth

2-4 years in role before advancement opportunity, depending on project success and organizational growth

Potential Next Roles

Quality Management Director Regulatory Affairs Manager Compliance Manager Training and Development Director

Company Overview

ORGENTEC Diagnostika GmbH

Global leader in diagnostic test systems for infectious and autoimmune diseases, part of the Sebia Group

Market leader with international presence in over 100 countries
Strategic position in German pharmaceutical sector with global reach
Professional environment with strong focus on quality and innovation, balanced with employee development
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