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Spec 2, Quality Document Sys Mgmt
Ref No.: 18-09467
Location: San Diego, California
Business Systems Analyst I ​
San Diego, CA
1+ Year

Summary
The Business Systems Analyst I is responsible for assisting in process definition and development of documentation related to the quality and accuracy of data entered into the LSRR operational systems. Executes transactions in these operational systems for product lifecycle data as defined through documented processes. Coordinates and completes required data entry for material introduction, change and discontinuation through the defined processes. Participates in the analysis of master data and communicates to the business data findings based on this analysis. Works in systems within an ISO compliant environment, creating and maintaining required system documentation for the business. Provides business support for Functional Excellence improvements to the Global Product Development System (GDPS) and other Continuous Improvement projects. Coordinates and collaborates cross-functionally with all areas of the business relating to product lifecycle data management. Typically requires detailed instructions on most work assignments.

Duties and Responsibilities

Business Systems Development

•Assists in identifying and evaluating system solutions and procedures which meet user requirements.
•Participates in analysis of business requirements, cross-functional information dependencies and systems impacts.
•Documents business and system processes.
•Maintains close working relationship with appropriate business partners to insure system functionality accurately represents data.
•Explores enhancements and other functionalities of the business system to maximize the efficiency of LSRR business systems.

Information Integration & Documentation

•Partners with applicable departments/units to ensure cross-functional integration of information and processes.
•Reviews functional specifications to ensure that business requirements are met.
•Communicates data standards, assisting with data integrity maintenance during database conversions.

Subject Matter Expertise

•Develops and builds knowledge of LSRR business processes
•Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements
•Participates in activities that review processes to recommend changes and process improvements where justifiable.

Policies and Procedures

•Follows all Environmental, Health and Safety (EH&S) policies and procedures. Participates in EH&S programs.
•Takes responsibility for safety in immediate work area. Notifies supervisor of all observed hazardous conditions or unsafe work practices. May provide recommendations on maintaining the safety of the work environment.
•Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
•Performs other related duties and assignments as required.

Qualifications

•Typically requires a Bachelors Degree in a scientific, technical, or business discipline with a minimum of 1 year experience working in computer databases, integrating and translating business processes into operational systems. High School GED/Diploma required, candidates with experience equivalent to a Bachelor's Degree will be considered

•Demonstrated knowledge of MS Office and proficient with MS Excel and/or other similar databases

•Basic understanding of SAP functionality.

•Experience within a medical, pharmaceutical or biotechnology environment, or equivalent combination of related education and experience is preferred.

•Knowledgeable of structured documentation and change control systems, tools for process improvement, Quality System Regulation, ISO 9000 and, where applicable, GMP guidelines preferred

•Familiar with structured phase-gate product development and portfolio management processes preferred
•Effective written and oral communication skills
•Ability to follow established policies and procedures
•Strong interpersonal skills
•Demonstrated results oriented capabilities
•Good analytical and problem-solving skills