LIMS BUSINESS ANALYST

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About the role:

Join Takeda as a LIMS Business Analyst where you will configure, support, maintain and administer LabWare LIMS database and electronic lab notebooks (ELN). You will collect and store data for pharmaceutical commercial operations. You will interpret needs of the business through analysis to create LIMS set up needs. As part of the Quality Control team, you will report to the Senior Manager, QC Chemistry.

How you will contribute:

• You will configure and maintain LabWare LIMS modules to support QC testing, inventory management, raw material testing/release, cleaning validation and integration with other computerized site systems.

• You will provide sound technical subject matter expertise on local and multi-site LIMS projects.

• You will configure static and master data within the LIMS.

• You will conduct validation of LIMS subroutines, analyses and other code based functionality.

• You will assist with writing and execution of test scripts.

• You will be the primary contact for users to troubleshoot LIMS issues.

• You will be the LabWare LIMS trainer for site personnel.

• You will ensure system is compliant with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.

• You will be the System administrator for all QC computerized systems such as Empower, HPLC, Endotoxin Detection Systems.

• You will implement CAPAs to address LIMS related corrections and ensure CAPAs are completed within assigned time frame.

• You will write/update LIMS related SOPs, Work Instructions, Protocols, and other system specific documentation.

Minimum Requirements/Qualifications:

• Bachelors or Master's Degree in life science or IT.

• 3+ years of experience in configuration and administration of Laboratory Information Management Systems (LIMS).

• You will have experience supporting and integrating lab applications in a regulated industry.

• You will have experience with SQL, Crystal Reports, programming.

• Experience with change management with LIMS required. LabWare LIMS.

• Experience with 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance.

• You will have knowledge of cGMP manufacturing.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision

• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

• Health & Wellness programs including onsite flu shots and health screenings

• Generous time off for vacation and the option to purchase additional vacation days

• Community Outreach Programs and company match of charitable contributions

• Family Planning Support

• Professional training and development opportunities

• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.