Advancing medicine to save lives. Together.
Thanks to many decades of experience and our passion for what we do, we make an essential contribution to the global availability of biopharmaceuticals, especially for patients with rare and serious diseases.
Rentschler Biopharma SE is a leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. We offer customized full-service solutions for bioprocess development and the production of complex biopharmaceuticals. As a German family-owned company with an international footprint and global reach, we combine experts, expertise and years of experience to develop best-in-class solutions – together with our clients.
Rentschler Biopharma has approximately 1,400 employees and is headquartered in Laupheim, Germany, with a site in Milford, MA, USA. In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.
As an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM! Open, respectful cooperation characterizes our working environment, where quality awareness, diligence and responsibility are our top priorities. With all the diversity of our talents in the Rentschler team, we pursue one vision together: advancing medicine to save lives.
The Quality Control Specialist, LIMS Master Data Builder arranges the creation and modification of Labvantage LIMS master data. The QC Specialist, LIMS Master Data Builder provides support to customers by updating or creating new master data. They will create and modify LIMS master data in accordance with global procedures and site change control.
Join our QC team with a quality mindset first to help make and release medicines for better lives. Our team is built on trust, respect, and integrity. The quality mindset is about operating with reliability, efficiency, and honest feedback.
Duties and Responsibilities
- Processes changes of varying complexity to existing LIMS Master Data
- Creates new Master Data of varying technical complexity
- Provide troubleshooting expertise and support for all LIMS activities and end users including instrument interfaces in conjunction with the IT Department
- Interface with site personnel on integration of sample management and electronic system processes to ensure optimal laboratory operations
- Provide hands-on, individual and group training(s) as needed for all user levels and develop training modules/protocols/work instructions accordingly
- Update LIMS, and corresponding departmental SOP and training materials as needed in accordance with global procedures and processes
- Proactively reviews master data and make changes as needed to support batch readiness
- Adapt, improve, and modify work instructions to optimize use of LIMS for day-to-day processes
- Develop understanding of manufacturing processes to provide thorough review and feedback for new material templates that are submitted by Product Development
- Provide ad hoc reports as requested by various departments
- Author quality system documentation such as change control, deviations, CAPAs, SOPs, work instructions
Qualifications
- Bachelor’s Degree in STEM
- 5+ years of relevant experience
- Thorough knowledge of regulatory issues and the impacts on discipline
- Experience in building Master Data in LabVantage LIMS
- Experience in GMP environment is preferred
- Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred
- Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
- Advanced and deep knowledge of principles, concepts, and practices in discipline, known as a SME in that discipline, and good knowledge of principles and concepts of other relevant disciplines
- Excellent organization and planning skills
- Strong attention to detail and ability to adhere to standards procedures
- Ability to drive functional, technical, and operational excellence
- Good understanding of the complexity, interactions, and dynamics within an international company
- Working understanding of systems and how they interact
Preferred Qualifications
- Laboratory testing experience is highly desirable
- Experience in creating custom fields in Empower software
- Strong MS Excel, PowerPoint, and Word skills. Microsoft Project skills
Working Conditions
- Normal office working conditions: computer, phone, files, fax, copier
- Working in the laboratory environment may be required when setting up LIMS master data
- Personal Protective Equipment must be worn as required
- Minimum travel required
Physical Requirements
- Frequent lifting up to 10 lbs; frequent standing/walking
- Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods
- PPE as required
