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.
