the professional possibilities within avantor
Site Quality Lead (m/
You think you have already seen everything in the world of Clinical Trials? We believe we have something new for you. Join our newest multi-million Euro investment to build a modern Sample Management hub for Clinical Trials projects.
Join us in our successful relationship with our most important customers. We are looking for a Site Quality Lead (m/f/d) in Kriftel.
- Modern site for the storage of sample and archive materials in a wide range of environmental conditions
- Seamless monitoring of storage areas, redundant supply systems
- 4000m² GLP certified areas for storage and sample preparation
- Space for 400 freezer units, various cold rooms, 20 cryogenic storage units
- Ideally connected to the European logistics network - only 15 km from Frankfurt airport
- Opened in November 2020
- Manage overall compliance of the EPL Archives facility with applicable standard operating procedures (SOPs) and regulatory requirements through internal facility and process-based inspections.
- Distribute findings to Archives Management personnel and staff for resolution and initiate SOP changes based on inspection findings.
- Maintain records of all inspection activities; identify, document and report deviations from applicable regulations and standard operating procedures; ensure appropriate corrective actions have been completed.
- Review and provide input for Quality Agreements for EPL customers.
- Manage QA client relationships which includes but is not limited to, client conference calls, client meetings, and complaints.
- Review and approve all complaints received by the Kriftel site.
- Own the revision of Standard Operating Procedures. Review each new or revised SOP.
- Assist in developing and providing applicable German and OECD GLP regulatory training for employees.
- Schedule/conduct assessments of critical vendors for suitability of use and distribute findings to Archives Management personnel and vendors for resolution.
- Host client inspections and perform associated duties (e.g., agendas, summary reports, and follow-up to ensure resolution of findings).
- Host regulatory inspections (e.g., daily summary reports, copying of materials).
- Identify and attend seminars and/or courses necessary to develop growth in the Quality Assurance field.
- Take part in company planning activities and/or committee assignments.
- GLP QA contribution to computer lifecycle activities such as validation, re-validation, change control and periodic review.
- Bachelor’s degree (MINT) or at least 5 years of applicable experience in quality assurance, preferably in the life sciences industry.
- 3 years of experience in GLP QA, preferred.
- Strong communication skills in german and english (both written and oral); french would be an advantage.
- Ability to work independently when necessary and participate in a team environment, with limited supervision
- Ability to balance and coordinate workload for multiple projects.
- Ability to use Microsoft Office (Word, Excel, Powerpoint).
- Team-oriented network of colleagues in a modern working environment
- Attractive and performance-oriented compensation
- Interesting, varying and independent activity
- Professional on-the-job training
Please have a look to our short video about the construction of the brand-new Biorepository in Kriftel. https://bit.ly/3vmmz50.
Dominik Kalthof, Talent Acquisition Partner
Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries.We set science in motion to create a better world.