Sr Analyst, IT Quality and Product Sciences System Location:Santa Monica, CA
Santa Monica, CA
100,000 - 200,000
Job Description:
Role:Sr Analyst, IT Quality and Product Sciences System
Location:Santa Monica, CA
Job description:
KEY RESPONSIBILITIES :
Required Skills And Knowledge:
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.