Katalyst Healthcares and Life Sciences
LIMS BA
Katalyst Healthcares and Life Sciences, Jersey City, New Jersey, United States, 07390
Responsibilities:
Business Analysis and Requirements Gathering:
Collaborate with stakeholders across R&D and QC labs to identify business needs and translate them into functional and technical requirements. Conduct gap analysis of existing systems, workflows, and processes to recommend improvements. Work closely with scientific teams to understand workflows, sample tracking, testing methodologies, and data management requirements. System Implementation and Support:
Lead the design, configuration, and deployment of laboratory informatics systems such as LIMS, ELN, CDS, and other relevant platforms. Partner with IT and third-party vendors to ensure system solutions align with scientific and business needs. Participate in user acceptance testing (UAT), ensuring successful validation of implemented solutions in compliance with regulations (e.g., FDA 21 CFR Part 11, GxP, ISO 17025). Stakeholder Communication and Documentation:
ct as a key contact between business units, IT, and external partners for project delivery and issue resolution. Develop and maintain comprehensive documentation, including business requirements, system workflows, and validation protocols. Facilitate workshops, meetings, and training sessions for laboratory staff and cross-functional teams. Data Management and Process Optimization:
Drive initiatives to streamline data capture, integration, and reporting across R&D and QC labs. Partner with data analytics teams to enable real-time insights and decision-making through dashboards and reports. Promote best practices for data integrity, governance, and compliance within lab environments. Regulatory and Compliance Alignment:
Ensure solutions meet applicable regulatory standards (e.g., GxP, GLP, GMP). Participate in audits and inspections, providing expertise on lab systems and data integrity processes. Requirements:
Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Computer Science, or related field. 7+ years of experience as a Business Analyst, preferably in Client, or life sciences industries. Strong experience in R&D and QC laboratory environments preferably in Client or Life science industry. Technical Skills
Hands-on experience with LIMS, ELN, CDS, and/or other lab informatics systems. Familiarity with SDLC, system validation, and requirements elicitation frameworks. Proficiency in data analytics tools (e.g., Power BI, Tableau) and database querying (SQL). Hands-on experience with flowcharting tools and the ability to create process flows reflecting current workflows in laboratories. Soft Skills
Excellent communication and interpersonal skills to work effectively with technical and non-technical teams. Strong analytical and problem-solving skills with a focus on innovation and process improvement. bility to manage multiple projects and priorities in a fast-paced environment. Familiarity with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, or ISO 17025. Experience working with Agile or hybrid project methodologies. Certification in Business Analysis (e.g., CBAP, CCBA) or laboratory informatics platforms (e.g., LabWare, STARLIMS). Experience with PLM and ERP systems is a valuable plus.
Collaborate with stakeholders across R&D and QC labs to identify business needs and translate them into functional and technical requirements. Conduct gap analysis of existing systems, workflows, and processes to recommend improvements. Work closely with scientific teams to understand workflows, sample tracking, testing methodologies, and data management requirements. System Implementation and Support:
Lead the design, configuration, and deployment of laboratory informatics systems such as LIMS, ELN, CDS, and other relevant platforms. Partner with IT and third-party vendors to ensure system solutions align with scientific and business needs. Participate in user acceptance testing (UAT), ensuring successful validation of implemented solutions in compliance with regulations (e.g., FDA 21 CFR Part 11, GxP, ISO 17025). Stakeholder Communication and Documentation:
ct as a key contact between business units, IT, and external partners for project delivery and issue resolution. Develop and maintain comprehensive documentation, including business requirements, system workflows, and validation protocols. Facilitate workshops, meetings, and training sessions for laboratory staff and cross-functional teams. Data Management and Process Optimization:
Drive initiatives to streamline data capture, integration, and reporting across R&D and QC labs. Partner with data analytics teams to enable real-time insights and decision-making through dashboards and reports. Promote best practices for data integrity, governance, and compliance within lab environments. Regulatory and Compliance Alignment:
Ensure solutions meet applicable regulatory standards (e.g., GxP, GLP, GMP). Participate in audits and inspections, providing expertise on lab systems and data integrity processes. Requirements:
Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Computer Science, or related field. 7+ years of experience as a Business Analyst, preferably in Client, or life sciences industries. Strong experience in R&D and QC laboratory environments preferably in Client or Life science industry. Technical Skills
Hands-on experience with LIMS, ELN, CDS, and/or other lab informatics systems. Familiarity with SDLC, system validation, and requirements elicitation frameworks. Proficiency in data analytics tools (e.g., Power BI, Tableau) and database querying (SQL). Hands-on experience with flowcharting tools and the ability to create process flows reflecting current workflows in laboratories. Soft Skills
Excellent communication and interpersonal skills to work effectively with technical and non-technical teams. Strong analytical and problem-solving skills with a focus on innovation and process improvement. bility to manage multiple projects and priorities in a fast-paced environment. Familiarity with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, or ISO 17025. Experience working with Agile or hybrid project methodologies. Certification in Business Analysis (e.g., CBAP, CCBA) or laboratory informatics platforms (e.g., LabWare, STARLIMS). Experience with PLM and ERP systems is a valuable plus.