Precision Technology is looking to hire a Business Analyst with experience implementing and supporting GxP-regulated laboratory applications in a life sciences environment. As a member of the IT GxP Compliance team, the Information Technology Business Analyst will be responsible for assisting with the lifecycle management of the applications used to support a range of regulated processes and activities across the manufacturing and testing business. They will work with stakeholders to ensure business needs are accurately captured and corresponding system solutions are fit-for-purpose and achieve desired results. The role requires a high degree of autonomy and an ability to work at a fast pace.

Essential Job Functions:

• Learn and understand existing systems and business processes; develop and maintain a robust awareness of how the business operations work and help stakeholders explore technology possibilities to more effectively execute in their roles.
• Work in partnership with stakeholders to improve business processes impacted by technology changes.
• Take on complex, high-profile projects.
• Perform enterprise analysis by planning and scoping several inter-related initiatives and helping senior-level business stakeholders make informed decisions about which initiatives to execute and how to execute.
• Mentor associate and mid-level business analysts in the organization.
• Lead and facilitate teams of cross-functional subject matter experts. Build strong and positive working relationships with all functional areas across the company and understand their needs.
• Use techniques such as focus groups and requirements workshops to elicit, analyze, and document clear and concise user requirements/stories in collaboration with business departments to achieve their desired results for system features or process changes.
• Use visual modeling techniques such as work-flow diagrams or wireframe prototypes to identify gaps between business requirements and existing technology solutions.
• Assist with functional requirements specification using system analysis techniques and methods.
• Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements.
• Assist with creation of test plans and detailed test cases to validate that functional requirements are met. When appropriate, lead user acceptance testing (UAT) efforts to ensure the software implementation meets the needs of business end users. Maintain a log of any issues identified during testing.
• Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements

• Develop system & user acceptance testing scenarios based on the business process and requirements.
• Assist with creation of test plans and detailed test cases to validate that functional requirements are met.
• Participate in the planning, scheduling, and oversight of user acceptance testing (UAT).

• Participate in GxP qualification/validation activities as needed including writing, reviewing, and executing validation protocols.
• Ensure system configuration specifications, operating procedures, and application integration documentation is delivered and maintained.
• Provide knowledge transfer and support to business operations teams
• Post-implementation, evaluate progress made against the business objectives for a project to show the extent to which they were fulfilled; suggest follow-up projects and initiatives as needed to fully realize the intended objectives.
• Document business requirements for system enhancements and collaborate with IT to ensure effective development and testing needed for successful solution deployment.
• Support continuous business process improvement as it relates to laboratory applications.

Education / Experience:

• Bachelor’s degree in in Computer Science/Information Systems, Life Sciences, or equivalent industry experience
• Minimum 6-8 years’ experience as a business analyst supporting major business applications
• Minimum 4 years’ experience supporting GxP laboratory applications in the life sciences, biotech, pharmaceutical or similar scientific industry

• Demonstrated experience with SDLC processes, iterative development methodologies, and computer systems validation (CSV)

• Experience communicating with colleagues, senior leaders, business partners, and vendors, to ensure collaboration, efficiency, and service excellence.

Knowledge / Skills / Abilities:

• Thorough knowledge of GxP, FDA 21 CFR Part 11, and EudraLex Annex 11 regulations

• Understanding of GAMP 5 guidance
• Proven implementation and life cycle planning of regulated laboratory applications
• Experience with GxP laboratory systems such as CMMS, Blue Mountain RAM, ELPRO, Rees Scientific, Empower CDS, SCADA, etc.
• Experience with ELN, EBR, LIMS, MES preferred
• Familiarity with emerging technologies such as equipment automation and robotic process automation preferred
• Understanding of Deviation/NCE/CAPA processes
• Well-developed business partnering, collaboration, and facilitation skills
• Ability to establish and sustain effective working relationships both within and between departments
• Effective organization and time management skills with ability to work under pressure and adhere to project deadlines in a fast-paced environment
• Ability to work independently, be self-motivated to accomplish tasks, and have great attention to detail
• Excellent analytical and decision-making skills
• Excellent oral and written communication skills
• Ability to communicate with all levels of the organization
• Proficient in Microsoft Excel, PowerPoint, Word, SharePoint, Visio
• IIBA Certification in Business Analysis and/or familiarity with the BABOK preferred
• Lean six sigma experience preferred

HYBRID

Precision Technology

precision-ts.com

LIMS BA POSITION

Overview

Outstanding opportunity to join and provide software application support and business analysis to deliver high quality, value-add systems to the business unit (ATU). This role will primarily focus on the implementation of new LIMS software (LabVantage LV Pharma LIMS) to support the ATU Testing business. Additionally, the role may provide support and analysis for other third-party applications, such as STARLIMS, Microsoft SQL Reporting Services, or for custom applications.

Responsibilities

• Provide technical support and analysis on business applications that include LabVantage LIMS, STARLIMS, Microsoft SQL Reporting Services, Crystal Reports, applications.
• Learn and understand existing systems and business processes; develop and maintain a robust awareness of how the business operations work and help stakeholders explore technology possibilities to more effectively execute in their roles.
• Elicit, analyze, validate and document business and functional requirements from end users to achieve their desired results for system features or process changes.
• Assist with identifying, modeling, and implementing future-state business system processes to align with functionality of the new LIMS software.
• Facilitate and participate in design brainstorming sessions with development and BI resources to determine how the future-state should function from a system perspective, while ensuring the design brings maximum value to the business given known constraints.
• Analyze and develop interim and future-state business system process documentation that articulates exactly what changes are required.
• Help business stakeholders envision the future and how their work will need to change to support the future. Work in partnership with stakeholders to improve the business processes impacted by the technology changes.
• Approach problem solving and system design from end user experience perspective, using user-centered design principles and encouraging intuitive and streamlined UIs/workflows when possible.
• Assist with functional requirements specification using system analysis techniques and methods.
• Assist with creation of test plans and detailed test cases to validate that functional requirements are met. When appropriate, lead user acceptance testing (UAT) efforts to ensure the software implementation meets the needs of business end users.
• Assist with systems integration design to deliver maximum efficiency and business value, while considering information flow and data requirements.
• Lead teams of users through support meetings, reviewing key points of concerns and escalating where necessary. Build strong and positive working relationships with all functional areas across the company and understand their needs.
• Review and validate deliverables with appropriate business and technology stakeholders.
• Train end users to ensure they understand all process and procedural changes. Collaborate with training staff to create appropriate training materials and deliver the training.
• Post-implementation, evaluate progress made against the business objectives for the project to show the extent to which they were fulfilled. Suggest follow-up projects and initiatives as needed to fully realize the intended objectives.
• Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.

Qualifications

• 8 years of relevant experience or equivalent
• Bachelors’ degree or equivalent experience

Knowledge / Skills / Abilities:
• 8 years of experience performing business analysis and supporting major business applications. (Experience in Life Science Industry will be Strongly Preferred )
• Demonstrated knowledge and experience of LIMS configuration and end to end system implementation
• Ability to translate user specifications into system functionality requirements
• Experience of implementing Laboratory tools and solutions
• Strong working knowledge of GxP software applications
• Strong working knowledge and understanding of laboratory functions and processes
• Previous experience implementing and/or supporting LIMS software (LabVantage LV Pharma LIMS preferred)
• Troubleshooting skills, Facilitation skills
• Ability to communicate with all levels of the organization
• Ability to work well within a team environment and independently as required
• Proficient in Oral & Written communication skills
• Proficient in Microsoft (Excel, Word, Outlook, PowerPoint, Visio)