IT R&D Systems Analyst

Location
San Francisco, CA, United States
Posted
Sep 06, 2020
Ref
845
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

IT R&D SYSTEMS ANALYST

Position Summary:

The R&D Systems Analyst is responsible for the implementation and support of IT systems for the R&D and GxP business functions. The role will partner with the various business functions to provide technical support for R&D and IT related projects. This role will be responsible for providing tier 1/2 application support, and participate in business requirements, analysis, solution selection, implementation, support computer systems validation and vendor management.

This position will support the research and development (GxP and Non-GxP) organizations across multiple disciplines such as Serialization, Quality Management Systems, Learning Management Systems, Electronic Document Management systems, Computer Systems Validation, Regulatory Information Management System and Veeva eTMF.

Essential Duties and Responsibilities:

 

  • Responsible for providing tier 1/2 application support for all GxP systems
  • Field incoming problem tickets from end users to resolve enterprise applications and software issues for GxP applications
  • Ability to work with and manage multiple vendors
  • Author and execute Installation Qualification (IQ), Operation Qualification (OQ), Performance qualification (PQ) documents for GxP applications
  • Ability to execute protocols, perform testing sequences and change controls
  • Administer enterprise applications and maintain (patch), repair and manage new and existing systems in a regulated environment
  • Provide day to day and scheduled application support; respond to application support issues from multiple business customers
  • Test fixes and perform post-resolution follow-ups to ensure problems have been adequately resolved
  • Participate in system validation activities and collaborate with project team on Validation Plans, User/Functional Requirements, Risk Assessments, Validation Summary Reports….etc.
  • Ability to execute protocols, perform testing sequences and change controls
  • Test fixes and perform post-resolution follow-ups to ensure problems have been adequately resolved


Qualifications:

 

 

  • Bachelor's Degree in Computer Science/Business Administration or an equivalent level of education and experience
  • 3-5 years of experience in IT building and supporting GxP and related systems
  • Knowledge and experience working within an SDLC framework
  • Demonstrated experience working in a regulated environment including a thorough understanding of 21CFR Part 11
  • Prior experience working in the Life Science industry including pharmaceutical, biotechnology or medical devices
  • Experience with the following types of systems preferred: SAS, Regulatory Publishing, Document Control, Quality Management Systems, LMS, Adverse Events, and eTMF
  • Excellent organizational, interpersonal and customer service skills; excellent communicator with active-listening skills
  • Proven adaptability to shifting project schedules, priorities and assignments; able to make effective decisions under pressure
  • Demonstrated problem-solver in a dynamic, fast-growing team environment
  • Strong written and oral communication skills
  • Strong presentation and interpersonal skills
  • Exceptional analytical, conceptual and problem-solving abilities
  • Able to prioritize and execute tasks in a high-pressure environment
  • Highly motivated with the ability to drive results


Fit with GBT culture:

 

 

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.