Quality Control Specialist, Master Data Builder

About the role

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 an independent family-owned company, we live by the motto: Many hands, many minds - ONE TEAM!

Responsibilities

• Processes changes of varying complexity to existing LIMS Master Data
• Create 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
• Author quality system documentation such as change control, deviations, CAPAs, SOPs, work instructions

Qualifications

• Bachelor’s Degree in STEM
• 7+ 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

Pay

$105,000 - $120,000

Schedule

Normal office working conditions: computer, phone, files, fax, copier