CMC Operations Business Analyst from Joulé

North Wales, PA

About the Job

Job Title: CMC Operations Business Analyst
Location: North Wales, PA
Hours/Schedule: Mon- Fri 8am- 5pm
Type: Contract

Overview
Global Vaccine Manufacturer looking to add experienced Operations Business Analyst to their growing team!

Responsibilities

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 a nd IT teams to translate these requirements into technical specifications, ensuring that the developed solutions align with operational needs.
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

Requirements

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

Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.