Quality Systems Senior Specialist-TrackWise Digital

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

As part of Integra’s Business Systems Team, the Quality Systems Senior Specialist is a seasoned professional with complete and in-depth conceptual and practical knowledge of Trackwise Digital platform. The candidate will lead delivery of system improvements and small to moderate projects with minimal guidance and direction to achieve operational targets. It involves:

• Collecting business requirements and analyzing impacts on the existing solution
• Applying knowledge of Trackwise’s best practices to internal processes to make recommendations for system design.
• Developing and configuring new and existing processes including analyzing business processes, evaluating user requirements and system specifications, process flows, group categories, terminology, states and activities, permissions, login accounts, record types and settings.
• Supporting business users during User Acceptance Tests execution.
• Reviewing scheduled system releases/upgrades and determining impact on Quality processes, system configurations, customizations.
• Working on issue resolution, coordinating with support teams or vendors when necessary.
• Working with IS peers on the integration of Trackwise platform within the Integra IS landscape.
• Creating validation deliverables such as test scripts, URS documents, FRS and Configuration Specification documentation following Integra’s Computer System Validation and Change control process to maintain the system in a validated state.
  
  

To perform this job successfully, the individual must be able to perform each essential duty satisfactorily:

• Solves complex problems exercising judgment based on the analysis of multiple sources of information.
• Understands business challenges, provides recommendation on Trackwise functionalities to cover the Quality processes (CAPA, Audit, Complaint, Supplier Quality Management, Non-Conformance…) and contributes to process improvements.
• Works to build consensus within cross functional project teams.
• Shares their Trackwise expertise with support team and business Subject Matter experts.
• Leads system improvements and small to moderate projects with minimal guidance and direction
• Considers operational constraints and regulatory factors for solution delivery as per project initial scope, budget and planning and in respect of internal processes for project computer systems validation and change control management.
  
  

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• BA/BS degree in Computer Science or Software Engineering.
• 8 years of relevant experience in pharmaceutical/medical device industry. 4-5 years of proven experience in an analytical or business/quality systems environment.
• Technical knowledge of Trackwise Digital system is a must-have. Expertise on Supplier Quality Management or Non-Conformance Trackwise Digital modules are nice to have.
• Expertise on TrackWise On Prem, Crystal Reports, Power Apps and Power Platform are nice to have.
• At least, involvement in one Trackwise Digital project implementation from project planning to go live.
• Knowledge of GxP, GAMP5, 21CFR Part11 and industry best practices.
• Thorough understanding of the principles of computer systems validation, SDLC methodologies and testing best practices.
• Strong written and verbal communication skills ensuring the ability to interact with the business, peers and vendors in a professional manner.
• Ability to work well with culturally and geographically diverse teams
• Ability to work independently with minimal supervision.
  
  

Additional details:

This role is hybrid between Princeton, NJ and remote. Office days are Tuesday, Wednesday and Thursday.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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