Life Scientist, Engineer - Quality Associate Clinical Trials (m/f/d)

Beschreibung

Brooks Life Sciences (Germany) GmbH, former BioStorage Technologies and a subsidiary of Brooks Automation, is a global leader in biological sample processing and archiving, sample management and cold chain logistics.
The safe storage of samples takes place at precisely controlled temperatures at our sites in Indianapolis (USA), Griesheim and Singapore. Our international customers include pharmaceutical and biotechnology companies that conduct clinical trials.As EU Senior Quality Associate you will maintain and implement policies and procedures which result in attaining quality goals and GxP requirements. You will provide direction to all personnel regarding BioBank compliance to all GxP guidelines. As a member of the Quality Assurance team you will contribute to assuring compliance to established QMS standards and for continuous improvement of the QMS system.

Location: Griesheim, near Darmstadt

EU Senior Quality Associate responsibilities:

• Responsible for the planning, implementation and action tracking of internal and external audits (e.g. customer audits).
• Daily work will be accompanied by an electronic document management system, reviews of Change Control, CAPAs and Effectiveness Checks
• Participate in and lead initiatives to develop and implement compliance and appropriate Quality control policies.
• Review policies and procedures before they are finally approved to assure appropriate best practices resulting in standardized and streamlined global processes and improved quality.
• Review validation documents including, but not limited to, freezer mapping, remote alarm monitoring system and BioInventory.
• Support the activities to maintain the global QMS system
• Follow up on supplier performance issues
• Analyze Quality Agreements and maintain the established system
• Assist with training of employees on quality related topics.
• Assist with implementation of quality system in global branches of the companies technologies.
• Participate in committees and public relations projects as requested.
• Cooperate with Technologies staff to achieve goals and maintain harmonious working relationships among employees.

• Degree in Life Science/Engineering.
• Experience in the areas of Quality Assurance, Auditing, writing SOPs and maintaining a QMS system
• Experience in GxP Practices.
• Experience with FDA regulations, EMA regulation, ISO 9001 regulations
• Your way of working is defined by analytical and creative thinking, strong communication skills and the strength to adapt quickly to dynamically changing circumstances.
• You enjoy working in a team on an international and matrix organized basis.
• You are a proficient user of Microsoft Office products including Outlook, Word and PowerPoint.

• Independent work at an international level.
• A pleasant working environment with flat hierarchies and a family atmosphere, by being a part of a very international team.
• Permanent employment contracts.
• 30 days of vacation.
• Life Insurance, Company Pension Plan, Stock Options.