GxP Lab Computing Analyst
Zifo
Unix
Job Level
Mid-LevelSenior
Tech Stack
Unix
About the role
- Provide consulting, analytical and technical laboratory services including multivendor instrument and lab IT support
- Provide in-lab validation/compliance services when applicable and assist with IOPQ
- Analyze customer needs and gaps and propose solutions for desired state
- Work with business users and managers in conjunction with internal Zifo support team
- Requirements Management: understand problem statements, define scope, gather requirements, analyze current state business processes, assist with validation/compliance activities, and build process improvement plans
- IT Consulting: analyze gaps/opportunities, evaluate industry trends, evaluate vendor solutions and facilitate demos/proofs of concept, recommend process improvements
- Customer Liaison: meet with internal/external service groups, liaise between system/lab owners and third parties, provide weekly planning schedules, participate in monthly operational reviews and quarterly metrics reporting
- On Site Lab IT Support: perform break/fix support for instrument-connected systems, implement Windows security policies, ensure adherence to client corporate policies, act as technical support contact for field service engineers and vendors
- Serve as technical SME for new system validation and change management
- Create and maintain physical inventory of lab equipment, PCs, software and other pertinent information
- Perform system preventative maintenance based on client schedules
Requirements
- Excellent customer service skills complemented by an ability to listen to and interpret client requests
- Ability to troubleshoot complex instrument and technology issues
- Strong oral and written communication skills
- Ability to identify, track and complete tasks for multiple projects
- Knowledge of laboratory safety practices as defined by the company and/or customer’s site safety code
- In-depth understanding in one or more of: Drug Discovery & Development Processes; Clinical study planning & Data management; Lab Workflows; Chemical & Biologics material Management; Sample Management; Robotic Systems Integration & Qualification
- Requirements Management and onsite Validation/Compliance support experience (IOPQ)
- IT consulting skills
- Customer liaison and stakeholder coordination experience
- Break/fix support for instrument-connected systems
- Implement Windows based security policies
- Ensure adherence to corporate policies through reporting & compliance programs
- Technical subject matter expertise for system validation and change management
- Create and maintain physical inventory of lab equipment, PCs, software
- Perform system preventative maintenances
- Bachelor's/Master's degree or equivalent in Pharmaceutical, Bio-technology, Bio-medical, Chemical Engineering
- Demonstrated domain area knowledge
- Excellent analytical and interpersonal skills
- Operations KPI and Metrics tracking
- Optional: Familiarity with US and International Regulations and Standards (GLP, GMP, 21 CFR Part 11, Part 210, Part 211, Part 820)
- Technical Skills: Operating System familiarity with at least 1 of Unix, Windows, MVS
- Change Control Management and Risk Management
- Office Tools proficiency: MS Word, Excel, PowerPoint
- Office productivity tool proficiency in at least 1 of Visio, MS Project, SharePoint
