Process Documentation Analyst - Hybrid / Remote

Process Documentation Analyst - Hybrid / Remote New    days ago Post Date    AX Requisition

POSITION SUMMARY :

Please apply using a laptop or desktop computer.

This position works closely with business units, project teams, process owners, managers, and subject matter experts (SME) to translate business requirements into operational processes. Works with Quality Assurance and Regulatory Affairs to ensure regulatory and other legal requirements within operations processes are met. Collaborates across multiple departments, acting as liaison, to ensure alignment of documents and procedures and facilitate process development and process improvement activities. Works with leadership and stakeholders to facilitate development and improvement of quality management systems and processes is a key role this position plays within the organization. Works with others to create and update processes and process maps that impact all document types located in our quality management system. While updating documents, this position educates employees in shared services about our document management and change control process.  This position can be remote (US) or hybrid. LI-Remote LI-Hybrid

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ACCOUNTABILITIES :

Process Analysis and Development :

• Works with leadership and stakeholders to identify needed process and document development or change. Estimates implementation timelines and communicates to stakeholders
• Facilitates process mapping. Captures detailed business process flows via process flow diagrams.
• Works closely and proactively with contributors and stakeholders to ensure timelines are met.
• Maintains and applies up-to-date knowledge of key regulations and standards related to the cellular therapy biological product manufacturing process (FDA Good Manufacturing Practice [GMP], Good Tissue Practice [GTP] and Good Documentation Practice [GDP]), as well as applicable international regulations.

Process Documentation :

Provides Subject Matter Expertise to Process and Project Work :

Other duties as assigned, in support of the organization’s mission and strategic objectives.

REQUIRED QUALIFICATIONS :

Knowledge of :

Ability to :

Education and / or Experience :

PREFERRED QUALIFICATIONS : (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

DEI COMMITMENT :

As part of our values, we are committed to supporting diversity, equity, and inclusion at NMDP / Be the Match. We actively celebrate colleagues' different abilities, sexual orientation, ethnicity, faith, and gender. Everyone is welcome and supported in their development at all stages in their journey with us.

Be The Match offers regular, full-time employees medical, dental, vision, life and disability, accident / critical illness / hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off / holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information :

Additional Information