- 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.
- 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.
- 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.
- 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
Brooklyn Park, MN