Posted to MedZilla on 10/13/2019


Takeda Pharmaceuticals

US-MN, LIMS Business Analyst R0011605-MZ


 
 

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Job Description

OBJECTIVES:

  • The position will configure, support, maintain and administer LabWare LIMS database and electronic lab notebooks (ELN) as it is used to collect and store data for pharmaceutical commercial operations.
  • Interpret needs of the business through analysis to formulate LIMS set up needs.

ACCOUNTABILITIES:

  • 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.
  • Provide sound technical subject matter expertise on local and multi-site LIMSprojects.
  • Configure static and master data within the LIMS.
  • Validation of LIMS subroutines, analyses and other code based functionality.
  • Assist with writing and execution of test scripts.
  • Primary point of contact for users to troubleshoot LIMS issues.
  • LabWare LIMS trainer for site personnel.
  • Ensure system is compliant with 21 CFR Part 11 and data integrity best practices for pharmaceutical environments.
  • System administrator for all QC computerized systems such as Empower, HPLC, Endotoxin Detection Systems, etc.
  • Execute CAPAs to address LIMSrelated corrections and ensure CAPAs are completed within assigned time frame.
  • Write/Update LIMSrelated SOPs, Work Instructions, Protocols, and other system specific documentation.
  • Complete mandatory training within required timeframe.
  • May perform other duties as assigned.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)

  • Bachelors or Master s Degree in life science or IT
  • 3+ years of experience in configuration and administration of Laboratory Information Management Systems (LIMS) preferred.
  • Experience supporting and integrating lab applications a plus.
  • Experience in a regulated industry preferred
  • Computer Training: Experience with SQL, Crystal Reports, programming
  • Experience with change management with LIMS required. LabWare LIMS preferred.
  • Experience with 21 CFR Part 11, data integrity best practices and computerized system regulatory compliance is preferred.
  • Work independently and have the ability to handle multiple tasks concurrently, and in a timely fashion.
  • Must be detail oriented, conscientious and have high reading comprehension skills.
  • Must be able to communicate effectively with supervisors and peers.
  • Must be able to read, write, and converse in English.
  • Good interpersonal skills and be able to work effectively and efficiently in a team environment.
  • Knowledge of cGMP manufacturing.
  • Must demonstrate effectiveness in empowerment, results orientation, and task completion.
  • Must be able to read and follow detailed written instructions and have good verbal/written communication skills.
  • Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.
  • Must have respect for individuals and the diverse contributions of all.

LICENSES/CERTIFICATIONS:

  • LabWare LIMS Basic Certification

PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position).

  • Position is mostly sedentary and will sit for long periods of time.
  • Occasional mobility within the office, including movement from floor to floor.
  • Repetitive movements: Constant finger/hand/wrist movements and occasional movement of head/neck while operating a computer.

TRAVEL REQUIREMENTS:

  • Willingness to travel to various meetings or training, this could include overnight trips.
  • Requires approximately 5% travel.

ADDITIONAL US SPECIFIC INFORMATION (FOR US RECRUITMENT ONLY): E.g. Number of years experience, ADA

ADDITIONAL EUROPE SPECIFIC INFORMATION (FOR EUROPEAN RECRUITMENT ONLY): This section should reiterate minimum/essential requirements for role

Locations

Brooklyn Park, MN

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time


Please visit our website at takedajobs.com

 
 


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