Overview
On Site
Full Time
Skills
Computerized System Validation
Acceptance Testing
URS
OQ
PQ
Corrective And Preventive Action
Continuous Improvement
Business Process
Collaboration
Business Cases
Quality Control
Management
Proposal Writing
Technical Drafting
Testing
Inspection
Science
ELN
Data Analysis
Analytical Skill
Test Methods
Technical Writing
Information Systems
Good Manufacturing Practice
Conflict Resolution
Problem Solving
Departmental Management
Mentorship
Coaching
Negotiations
Master Data Management
System Integration
LIMS
Enterprise Resource Planning
MES
Job Details
Position Summary:
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement.
Responsibilities:
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement.
Responsibilities:
- Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers.
- Provide electronic systems operational support and troubleshooting to end user.
- Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
- Own project, CAPA and deviation/ investigation related tasks and/ or continuous improvement efforts.
- Propose and implement improvements to electronic systems to optimize business process and improve efficiency. Collaborate with end users to develop business case.
- nticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives.
- nticipate and perform troubleshooting and problem solving independently.
- Train and mentor others on electronic systems use and operation.
- Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution.
- Facilitate design, testing and subsequent deployment of solutions.
- Support health agency inspection as equipment area subject matter expert.
- Perform other tasks as required to support the electronic systems.
- Bachelor's degree required, preferably in science or related engineering field.
- 6+ years of relevant work experience in LIMS, ELN and laboratory data analysis systems preferably in a regulated environment.
- Knowledge of analytical and microbiological test methods and environmental monitoring programs preferred.
- Demonstrated technical writing skills.
- Demonstrated experience with validation and/or maintenance of laboratory information systems.
- bility to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
- bility to work in a fast-paced team environment, meet deadlines and prioritize work.
- dvanced technical, problem-solving skills and logical.
- bility to communicate effectively with peers, department management and cross-functional peers.
- Mentoring, coaching, influencing, negotiating and personnel interaction skills.
- Must Haves Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.