DUTIES AND RESPONSIBILITES:
• Responsible for elicitation, analysis, and documentation of business requirements.
• Research and exploration of user requirements, costs, and benefits in support of documentation required for the demand management process.
• Responsible for analyzing the business needs to identify new processes and process improvements that will meet those needs.
• Documents current business processes and models to define requirements and/or gaps.
• Analyze detailed system factors including input/output requirements, information and paper flow, hardware, and software needs.
• Analyze “soft" system factors including roles, responsibilities, policy, culture, etc.
• Evaluate the impact of potential software and process changes on the organization.
• Develop and facilitate groups as necessary in pursuit of eliciting and defining requirements.
• Assist in the creation of the business case documentation.
• Understanding of architectural consistency and usability standards.
• Defines and develops user test cases and validates test results during testing.
• Executes unit and functional test cases.
• May conduct system demonstrations and training sessions, as well as participate in design/review of training content.
• Plays a third level support role by helping to troubleshoot and resolve issues with production systems.
• Participates in associate meetings and communicates any concerns to management.

QUALIFICATIONS AND REQUIREMENTS:
• Bachelor’s degree in computer science, Information Systems, Business, or another related field or equivalent work experience.
• Proven experience leading data migration requirements from legacy systems into a new ERP (Sage X3) environment
• Strong hands-on expertise in requirements elicitation, documentation, and management, with emphasis on data mapping, transformation rules, and validation
• Deep understanding of data structures, data quality, and migration best practices, with the ability to identify gaps and risks early
• Self-driven and accountable professional with strong stakeholder management and communication skills, able to drive outcomes with minimal oversight
• Working knowledge of Confluence and JIRA.
• Experience in any of the following business areas is desired: Sales operations, order entry, accounting, finance, procurement, warehouse operations, order management, and order fulfillment.
• Minimum of 3-5 years’ business analysis or systems analysis experience is preferred.
• Bonus: Sage X3 experience (ERP).

Associate is expected to operate at a proficient level across the following areas of technical knowledge and skill:
• Ability to organize and prioritize work.
• Detail oriented, proactive, creative, and efficient
• Intermediate level abilities in Excel, Outlook, PowerPoint, Visio, and Word
• Familiarity with application integration methods to include understanding of data mapping process.
• Ability to effectively work both independently and collaboratively in a team environment
• Ability to work on simultaneous and complex projects, with domain expertise in at least one business area.
• Expertise in ERP solution selection and implementation is a plus
• Ability to communicate effectively to both technical and non-technical audiences in written and non-written format
• Ability to work with all levels of associates
• Ability to work with minimal supervision in a very dynamic environment
• Ability to learn new systems and tools
• Knowledge of software development life cycle methodologies, processes, and procedures.
• Active listener
• Effective in a variety of formal/informal presentation settings: one-on-one, small, and large groups.

Job Title: Document Control Specialist

Location: Boulder, CO

Duration: 8 Months

Responsibilities:

Maintains all document files as related and assists in the archival of documents at the offsite storage location.
Issues and reconciles controlled documentation including logbooks, notebooks, controlled forms, batch records, and protocols.
Handles the document lifecycle using the site Training and Document Management System (TMS).
Plans and executes multiple tasks to ensure controlled documents are prepared on time, managed per procedures, and align with applicable regulations.
Generates, reviews, and approves labeling materials.
Represents Document Control (DC) in internal meetings, customer interactions, and Regulatory inspections.
Provides support on various other projects or tasks delegated by Document Control Supervisor
Possesses the ability to evaluate processes, identify efficiencies, and motivate change.

Required Skills & Qualifications:

High school Diploma or equivalent.
Skill in using computer software and hardware applications, including Microsoft products (Word, Access, and Excel) and the Internet.
Prior experience and/or training working in a GMP production environment
Ability to use, maintain, and train in the TMS system.
Ability to effectively present information and respond to questions from co-workers, managers, contractors, and customers.
Knowledge of GMP guidelines as well as international conference on harmonization (ICH) regulations pertaining to the production of APIs and drug products.

Document Control Specialist

Key skills

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