LIMS Laboratory Information Management System Analyst
LIMS Laboratory Information Management System Analyst
Ewing, NJ (onsite 3 days/week)
Long Term
Contract
They are doing a LIMS rollout. Need this person to interact with business and understand existing workflows know the different workflows from data perspective on how labs work. R&D Labs, how do the workflows and business processes work at this time, explain those to the implementation team. Viso diagrams. Act as bridge for both sites.
Translates the requirements
Ensure what s implemented during sprint is fitting business needs. If issues, call them out and be the business voice to the product vendor.
CPG is a nice to have. But will give preference to CPG
Tools for
Requirements they use ADO
For process workflows they use Vizio
KEYS: how well you understand the business and act with the business. Need very strong personality and comm to advocate for the business. The business group is doing the RnD of the various products they make and the packaging they do.
The Senior Business Analyst (BA) for Research & Development (R&D) and Quality Control (QC) Laboratories will act as the primary liaison between business stakeholders, IT teams, and laboratory personnel. The individual will drive the development, optimization, and integration of digital solutions supporting laboratory operations, ensuring compliance with regulatory requirements, and enabling data-driven decision-making in a scientific environment.
Key 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
- Act 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
Qualifications
Education and Experience
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Computer Science, or related field.
- 7+ years of experience as a Business Analyst, preferably in CPG, or life sciences industries.
- Strong experience in R&D and QC laboratory environments preferably in CPG 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.
- Ability to manage multiple projects and priorities in a fast-paced environment.
Preferred Qualifications
- 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
Munesh
,
CYBER SPHERE LLC
LIMS Laboratory Information Management System Analyst
Ewing, NJ (onsite 3 days/week)
Long Term
Contract
They are doing a LIMS rollout. Need this person to interact with business and understand existing workflows know the different workflows from data perspective on how labs work. R&D Labs, how do the workflows and business processes work at this time, explain those to the implementation team. Viso diagrams. Act as bridge for both sites.
Translates the requirements
Ensure what s implemented during sprint is fitting business needs. If issues, call them out and be the business voice to the product vendor.
CPG is a nice to have. But will give preference to CPG
Tools for
Requirements they use ADO
For process workflows they use Vizio
KEYS: how well you understand the business and act with the business. Need very strong personality and comm to advocate for the business. The business group is doing the RnD of the various products they make and the packaging they do.
The Senior Business Analyst (BA) for Research & Development (R&D) and Quality Control (QC) Laboratories will act as the primary liaison between business stakeholders, IT teams, and laboratory personnel. The individual will drive the development, optimization, and integration of digital solutions supporting laboratory operations, ensuring compliance with regulatory requirements, and enabling data-driven decision-making in a scientific environment.
Key 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
- Act 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
Qualifications
Education and Experience
- Bachelor's degree in Life Sciences, Chemistry, Biochemistry, Computer Science, or related field.
- 7+ years of experience as a Business Analyst, preferably in CPG, or life sciences industries.
- Strong experience in R&D and QC laboratory environments preferably in CPG 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.
- Ability to manage multiple projects and priorities in a fast-paced environment.
Preferred Qualifications
- 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
Munesh
,
CYBER SPHERE LLC