Quality Control Specialist, Master Data Builder (Contract)
Rentschler Biopharma•Milford, MA
•Hybrid
About The Position
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.
Requirements
- 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
- 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
Nice To Haves
- Experience in GMP environment is preferred
- Experience in quality system management (e.g., deviations, change controls, SOPs) is preferred
- Laboratory testing experience is highly desirable
- Experience in creating custom fields in Empower software
- Strong MS Excel, PowerPoint, and Word skills.
- Microsoft Project skills
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
Benefits
- In 2024, we joined the United Nations Global Compact, underlining our commitment to sustainability.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
