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 :

Creates / writes, reviews, edits, and updates essential documents (policies, standard operating procedures SOPs , work instructions, job aids, instruction manuals, forms, etc.

for assigned client projects or business units.

• Collaborates with subject matter experts (SME) and other key stakeholders for knowledge transfer of critical information regarding procedural requirements and process steps to be included in SOPs and other essential documents.
• Ensures appropriate stakeholder review and approval of assigned documents.
• Identifies training and communication requirements for new or revised documents in consultation with the Education & Training staff and operations process managers.
• Collaborates closely with training staff to ensure delivery of timely and appropriate communication and / or training to affected staff and stakeholders.

Ensures consistency between process documentation and training materials.

Provides Subject Matter Expertise to Process and Project Work :

• Coordinates across departments and systems to ensure accurate and timely launch of documents (network announcements, web content submissions, MasterControl, etc.)
• Participates on cross-functional project teams as assigned.
• Maintains active relationship and knowledge of operational department needs and activities.
• Actively contributes to strategic project development and maintenance.

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

REQUIRED QUALIFICATIONS :

Knowledge of :

• Process mapping. Strong writing skills with proven ability to produce high-quality documentation. Proofreading and editing.
• Familiarity with application of quality management principles within a regulated environment strongly desired.
• Highly proficient in Microsoft Office Suite software applications including Visio; proficient with document management software.

Ability to :

• Ability to quickly learn and synthesize new information.
• Advanced critical thinking skills.
• Ability to manage multiple projects and deadlines.
• Excellent interpersonal and customer service skills; proven ability to work collaboratively and flexibly with subject matter experts and stakeholders across multiple levels of the organization.
• Able to work effectively and efficiently, both independently and as part of a team.

Education and / or Experience :

• Bachelor’s degree, preferably in English, Communications, Business or Health Science-related discipline.
• years of relevant experience with process analysis and writing SOPs or process-oriented instructional materials. Experience working in a regulated environment within biomedical / bioscience field strongly desired.

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

Experience working in a regulated environment within biomedical / bioscience field strongly desired.

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

• Number of Openings :
• Pay Basis : Yearly
• Schedule : Full-time
• Driver Policy : No
• Job Family : Business Services
• Career Category : Established Leader / Established Professional
• Career Level :
30+ days ago