Senior Business Analyst

Job Summary:

The Senior Clinical Business Analyst plays a critical role in supporting laboratory technology initiatives with a strong emphasis on User Acceptance Testing (UAT), system validations, and regulatory compliance documentation. This position serves as a key liaison between laboratory operations, IT, quality, and external vendors to ensure that laboratory systems are implemented, validated, and maintained in accordance with regulatory standards and business needs.

The ideal candidate combines deep clinical laboratory knowledge with expertise in system implementation, validation methodologies, and regulatory documentation within a highly controlled environment (e.g., CLIA, CAP, FDA, GxP).

Main Duties Responsibilities:

Essential duties include but are not limited to:

UAT Leadership Execution

Lead and coordinate User Acceptance Testing (UAT) activities for laboratory information systems (LIS), middleware, instrumentation interfaces, and other clinical lab technologies

Develop UAT strategies, test plans, scripts, and acceptance criteria aligned with business and regulatory requirements

Partner with laboratory stakeholders to ensure test scenarios reflect real-world workflows and operational use cases

Facilitate defect tracking, triage, and resolution in collaboration with IT and vendors

Ensure traceability between requirements, test cases, and outcomes

System Validation Compliance

Plan and execute system validation activities in accordance with regulatory standards (e.g., GxP, FDA 21 CFR Part 11, CLIA, CAP)

Author and/or review validation deliverables, including:

Validation Plans (VP)

Requirements Specifications (URS/FRS)

Risk Assessments

IQ/OQ/PQ protocols and reports

Traceability matrices

Ensure systems are audit-ready and compliant with internal quality systems and external regulatory expectations

Support audit and inspection activities, including responses and corrective actions

Regulatory Documentation Quality Support

Develop and maintain SOPs, work instructions, and supporting documentation related to laboratory systems and processes

Ensure documentation aligns with quality management system (QMS) requirements

Collaborate with Quality Assurance to maintain compliance and support continuous improvement initiatives

Maintain document control and versioning in accordance with regulatory standards

Business Analysis Stakeholder Engagement

Gather, analyze, and document business and functional requirements from laboratory stakeholders

Translate complex laboratory workflows into system requirements and technical specifications

Serve as a liaison between laboratory operations, IT, vendors, and quality teams

Facilitate workshops, meetings, and process mapping sessions

System Implementation Optimization

Support system implementation, upgrades, and enhancements across laboratory platforms

Identify opportunities to improve efficiency, data integrity, and compliance through system optimization

Provide subject matter expertise on laboratory processes, informatics, and regulatory expectations

Education Experience:

Minimum Education Experience:

Bachelor’s Degree or Master Degree in Clinical Laboratory Science, Life Sciences, Health Informatics, or related field required

5-8 years of related experience in clinical laboratory operations, laboratory informatics, or business analysis

Strong experience with laboratory systems (LIS, LIMS, middleware, instrument interfaces)

Demonstrated expertise in UAT coordination and execution

Hands-on experience with system validation in regulated environments (GxP, CLIA, CAP, FDA)

Experience authoring validation and regulatory documentation

Preferred Education Experience (optional):

Experience with specific LIS platforms (e.g., Epic Beaker, SCC Soft, Sunquest, Cerner Millennium)

Familiarity with data standards (HL7, interfaces, instrument connectivity)

Experience in audit/inspection readiness and regulatory submissions

Knowledge of electronic document management systems (eDMS) and change control processes

Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and…