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Sr Analyst, IT Quality and Product Sciences System Location:Santa Monica, CA

Santa Monica, CA
2018-03-27 10:52:54

Job Type: Full Time only
Budget $: 100,000 - 200,000

Role:Sr Analyst, IT Quality and Product Sciences System
Location:Santa Monica, CA

Job description:

Employees and Contractors Please log onto your Internal Career Site to apply for this job
Company is a Gilead Company is seeking a highly motivated individual to join our information technology group to lead all Quality and Product Sciences/Development applications such as LIMS (Laboratory Information Management System), ELN (Electronic Lab Notebook), QMS (Quality Management System), Document Management system, Process Monitoring etc..
This will be a hands-on role within our Information Technology group and highly cross functional working closely with various business groups who deal with GxP systems.
This is a critical role at company to design, develop and support new and existing quality and product sciences systems.

KEY RESPONSIBILITIES :

Act as a system owner/subject matter expert for quality and product sciences systems like LIMS, QMS,
Quality Document Management system in a FDA regulated biotech or pharmaceutical organization.
Work closely with Quality and Product Sciences/Development business groups to understand their technology requirements and identify and implement best fit technology solutions to meet their needs.
Lead the complete life cycle management of quality systems used for functions like change management, quality assurance, Laboratory sampling/testing systems, quality document management, process monitoring and GxP training.
Design and configure QMS software solutions to incorporate new business processes.
Provide technical administration and support for LIMS, Quality Document Management and GxP training systems.
Collaborate with the Quality and Computerized system validation team to perform IQ/OQ/PQ, to facilitate validation activities; develop and/or execute test scripts as required.
Assist with the development and maintenance of the Standard Operating Procedures, Work Instructions, user guides, and other relevant documentation for quality systems administration.
Lead Quality Document Management systems life cycle from implementation through ongoing support.
Collaborate with infrastructure team to support hardware, network and database support for LIMS and other Quality systems.
Assist with change control impact assessments for any quality systems changes.
Participate in internal audit reviews of the system administration procedures and documentation.
Work with LIMS and other system vendors for upgrades, patching, bug fixes and support.
Design and develop integration between LIMS and other quality and manufacturing systems with lab instruments and other GMP and corporate systems like Oracle EBS, MES etc.
Provide analytics support to quality and product sciences business groups to deliver KPIs related to Quality data and process monitoring.

Required Skills And Knowledge:

BS or MS in a Life Sciences, Engineering, Computer science or related field.Minimum of 5-8 years of working within a GxP regulated setting (Laboratory,Quality, Manufacturing, IT) supporting quality and product sciences systems.
Knowledge of CGMP/ICH/FDA regulations with 21 CFR Part11. GAMP knowledge will be a plus.
2 years of hands on design development experience integration and middle ware technologies like JBoss, Web Logic, Apache, Java, XML etc.
Hands on configuration, administration, development and support experience with any LIMS, QMS and Document Management systems.
Experience with Lab vantage LIMS, Oracle Agile/QMS, Veeva Quality document system and Compliance Wire learning management system is highly desirable.
Experience in integrating LIMS and Quality systems with other internal and external systems like ERP and laboratory instruments.Good background in quality and laboratory informatics and data analytics.
Experience in designing and building quality and product sciences dashboards and KPIs for process monitoring and Quality metrics is desirable.
Experience with emerging cloud, SaaS and web technologies a plus.
Experience with defining business requirements and knowledge of business process definitions, application design/configuration and systems implementation and testing activities.
Experience with training and supporting end users with their day to day operations.
Ability to provide technical impact assessment of changes and deviation to systems and procedures.
Experience with change control and supporting systems validations.
Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines and Governance in a fast paced environment.
Strong written and verbal communication and presentation skills.
Proficient in tools like Power Point, Visio and other tools to develop process flows and presentations.
Quick learner and keeps current with emerging technologies in GxP space.Detail-oriented with expertise in problem solving, analytical and critical thinking skills.
Ability to assist infrastructure team on network, infrastructure and instrument qualifications and validations for regulatory requirements.
Company is a bio pharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care.
The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system\'s ability to recognize and kill tumors.