Summary

Our client is looking for a talented IT Quality System Analyst to own technical QMS solutions and provide technical support to the Quality organization. This person will focus on Documentation Management, Deviation, Investigation, CAPA, Change Control, and other areas within Quality and will collaborate with the business and vendors to identify functional and integration requirements for the QMS and with other strategic platforms. This person will play a crucial role in the design/development, deployment, and maintenance/support of the QMS validated state, including modifications from upgrades and software releases.

Responsibilities

• Establish/maintain QMS Data Analytics and Dashboards
• Elicit, develop, confirm, and document functional/user business requirements
• Transform the users’ requirements into functional requirements
• Work closely with Project Managers on issues, concerns, schedules of deliveries and completion estimates
• Turn objectives into work plans and guide execution. Utilize data for analysis and recommendations for solutions where possible. Establish and lead operational initiatives to deliver tactical results. Communicate to management updates on risks and opportunities to make sure desired results are achieved.
• Stay up to date with and demonstrate knowledge of current relevant US and global regulatory requirements/guidelines (e.g. cGMP, FDA, USP/EP/JP+). Update internal procedures to ensure compliance. Serve as area expert in field within the organization, also leverage other experienced staff SMEs.
• Face off with departments at various leadership levels regarding operations and projects. Communicate direction to team, take action on issues, execute on decisions that keep the organization progressing forward, monitor, and report on progress.
• Align work plans and priorities with those of other units. Balance the need for adequate planning with the need for action. Establish realistic timelines with steps outlined in the right sequence.
• Accept needed change, constructively deal with problems that do not have clear solutions or outcomes, work to clarify situations where information, instructions, or objectives are ambiguous. Address problems without clear solutions, making substantial progress.
• Operate individually and as a team with quality and attention to detail.
  
  

Qualifications

• BA/BS degree in Information Technology or Computer Science with 3-5+ years progressive experience in data integration
• Strong understanding of QMS Technologies specifically TrackWise Digital implementation and maintenance.
• QMS vendor management experience while implementing the solution and/or new functionality as well as migrating legacy data into the QMS
• Knowledge of integrating the QMS with other strategic technologies such as ERP, LIMS, LMS etc.
• Experience in the following areas highly preferred: Quality Systems & Document Management, Quality Assurance, Computer Systems Validation, GxP, Validated Change Control and Product Life Cycle Management.
• Understanding of Computer Systems Validation and the full Software Life Cycle management
• Experience working in GxP validated environment and creating and executing validation documents
• Superb written and verbal communication skills.
• Excellent collaboration skills with the ability to work in a team dynamic across multiple functional organizations.
• Independent positive leader.
• Experience in the life science industry or like industry is a must have
• Strong analytical, troubleshooting, and problem-solving skills.
• Up to date SME level knowledge of modern industry best practices, implementation and procedures for Quality Management Technologies and applicable regulatory requirements. SME level knowledge of and previous experience with relevant Quality Management System software, validation, processes, budget planning and cost containment, and project planning/execution preferred.