CMC Business Analyst - Dale Workforce Solutions

Client: pharmaceutical industry
Job: CMC Business Analyst
Job type: long-term contract
Location: Hybrid in West Point, PA

Summary:

• We are seeking two skilled Technical Business Analyst to play a vital role in our Chemistry, Manufacturing, and Controls (CMC) operations team.
• The ideal candidate will support the Strategic Operation leads and collaborate with various stakeholders to gather, analyze, and document business requirements for systems and dashboard implementation and enhancements.
• They will work closely with the CMC Operations team and IT teams to translate these requirements into technical specifications, ensuring that the developed solutions align with operational needs.
• This requires their ability to communicate effectively with stakeholders will be essential, as they will participate in meetings and workshops to clarify team objectives and serve as a point of contact for any inquiries.

• Requirements Gathering: Collaborate with stakeholders in CMC operations to gather, analyze, and document business requirements for new system implementations and enhancements.
• Technical Analysis: Translate business requirements into technical specifications, working closely with IT teams to design and develop solutions that meet operational needs.
• Documentation: Create and maintain comprehensive documentation including business requirements documents (BRDs), functional requirements documents (FRDs), process flows, and use cases.
• Stakeholder Communication: Facilitate meetings and workshops with stakeholders to ensure clear understanding of project objectives and requirements. Serve as the primary point of contact for any questions or concerns.
• Testing and Validation: Develop and execute test plans, test cases, and user acceptance testing (UAT) scenarios to ensure that IT solutions meet business needs.
• Requirements Gathering: Collaborate with stakeholders in CMC operations to gather, analyze, and document business requirements for new system implementations and enhancements.
• System Implementation: Oversee the planning and execution of new system startups, including coordinating efforts between cross-functional teams (e.g., Quality Assurance, Regulatory Affairs, and IT).
• Process Optimization: Assess existing CMC processes and systems, identifying areas for improvement and recommending innovative solutions to enhance efficiency and compliance.
• Data Management: Collaborate with CMC Ops Strategic Lead to define data requirements, and drive data integrity efforts in CMC systems.
• Successfully engage in multiple initiatives simultaneously.
• Work independently with users to define concepts and under direction of project managers.
• Drive and challenge business units on their assumptions of how they will successfully execute their plans.
• Strong analytical skills required, including a thorough understanding of how to interpret business needs and translate them into application and operational requirements.
• Serves as the conduit between the internal customer community and the software development team through which requirements flow.
• Develop requirements specifications according to standard templates, using natural language.
• Collaborate with developers and subject matter experts to establish the technical vision and analyze tradeoffs between usability and performance needs.
• Be the liaison between the business units, technology teams and support teams.

• Education: Minimum Bachelors.
• Required Technical Skills: ME office Suite, Veeva Vault, Power Bi, Dashboard.
• Years of Experience: 6-8.
• Pharmaceutical/CMC Background is highly preferred.
• Exp. with System Implementation and change management.