Quality Control Specialist III jobs in United States
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TakedaPharmaceutical Nordics AB · 13 hours ago

Quality Control Specialist III

Takeda is transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. They are seeking a QC Specialist III to lead the transformation of QC laboratory operations through design, configuration, and enhancement of LIMS and related QC informatics platforms.

Pharmaceuticals

Responsibilities

Lead the transformation of QC laboratory operations through design, configuration, and enhancement of LIMS and related QC informatics platforms
Apply AGILE methodologies to plan, prioritize, and manage LIMS system changes and releases
Serve as the primary system owner for QC LabWare LIMS, focusing on configuration, lifecycle management, data integrity, and alignment to business processes
Maintain deep expertise in LabWare setup, including master data structures, workflows, templates, calculations, and interface design
Execute full lifecycle implementation of LabWare changes—requirements, design, configuration, testing, validation, and deployment
Evaluate and implement LIMS functionalities and integrations that streamline QC workflows and reduce manual effort
Act as SME for QC systems such as LabWare, MODA, and associated digital interfaces to support system design decisions and user story development
Customize and optimize LIMS workflows and user interfaces to enable accurate data capture and standardized testing
Maximize use of LIMS and connected tools (e.g., EM, LES, equipment interfaces) to enhance performance and data integrity
Support data science and analytics projects through high-quality, structured data extraction from LIMS and QC systems
Assist with creation of analytical and reporting tools to monitor QC trends, robustness, OOS/OOT rates, and turnaround time
Collaborate with QC, IT, Digital, Validation, Manufacturing, and Quality Systems on LIMS enhancements, integrations, and validation strategies
Participate in global and local informatics forums to support harmonization of QC processes and data structures

Qualification

LabWare LIMSQC operationsData integrityAGILE methodologiesAnalytical skillsStakeholder influencingChange controlValidation managementCommunication skillsCollaboration skills

Required

Bachelor's degree in science, engineering, or another technical field
3+ years of related experience
Strong understanding of QC operations, GxP, and data integrity principles
Demonstrated hands-on proficiency in LabWare LIMS, including configuration, master data management, workflow design, and system optimization
Experience supporting change control, validation, and LIMS lifecycle management
Ability to design and implement paperless digital solutions within QC environments
Strong analytical background, with experience using QC/LIMS data to support decision-making
Ability to manage multiple system changes and projects while maintaining compliance and quality standards
Strong communication, collaboration, and stakeholder-influencing skills
Experience working in AGILE or hybrid project environments

Preferred

Bachelor's or Master's degree in Life Sciences, Engineering, Computer Science, or a related field
Advanced LabWare LIMS experience and integration knowledge
Experience with digital QC tools such as ELN, CDS, or MODA

Benefits

Medical, dental, vision insurance
A 401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
A tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation

Company

TakedaPharmaceutical Nordics AB

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Funding

Current Stage
Early Stage
Company data provided by crunchbase