IT Quality Systems Analyst

About the position

The IT Quality Systems Analyst is responsible for performing IT end-user support and managing delivery of laboratory and quality systems at the Indivior Manufacturing Facility in Raleigh, NC. This role will be a key contributor to impact the delivery of new system implementations to support the local and global sites. Role is responsible for performing operational/maintenance activities for systems and technology at Raleigh site and other global sites. When necessary, this role should partner with application vendors for their specific systems/technology to ensure functionality, maintenance, and operations to meet business needs. Role will contribute business process, technical configuration, and implementation experience to ensure quality delivery of IT systems and lab technology. The role will ensure consideration and compliance with all company standards.

Responsibilities

• Performing system/technology maintenance (e.g., upgrades)
• Monitoring systems/technology (e.g., backups)
• End-user support
• Audit Support
• Authoring required Installation Qualification, Operational Qualification and Performance Qualifications for Qsystem deployment
• Creating required deliverables as part of Indivior's internal SDLC for upgrades, new installations, etc.
• Ability to develop and maintain effective relationships with internal and external stakeholders
• Project and vendor management
• Partner with IT Security to ensure systems are compliant with IT security standards
• Supporting IT integrations and business process improvements

Requirements

• 4-year Bachelor's Degree in a Scientific or technical discipline with focus on Information Technology or Bioscience
• Pharmaceutical Lab IT experience and business process understanding at a GMP facility, preferably from working with/in multinational Pharma environments
• Understanding of life science industry applications
• Demonstrated experience of life science validation, audit requirements, including risk-based methodologies
• Strong knowledge of global regulatory requirements of GMP, GCP, GLP, GDP and/or other domains
• Customer and results orientated personality
• Effective communication and team skills
• Support, diagnostic and problem-solving skills experience
• Flexibility in thinking/action and pragmatic in solving problems
• Fluency in English

Benefits

• 3 weeks' vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Gym, fitness facility and cell phone discounts