At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Brief Job Description

The Senior Lab Informatics Administrator is a cross-functional position in nature, the primary mission being to provide informatics support for local Quality Control Lab Systems (Chemistry, Microbiology, Incoming Quality labs, and Aseptic Control Team).  The secondary focus of this position is to cross train in Enterprise Lab informatics systems (SmartQC, GQCLIMS, Empower, Electronic lab notebook, etc.) and support lab needs within those systems. 

Job Responsibilities

Works independently to provide a high level of support for the QC Analytical, QC Microbiology, Incoming Quality control departments including but not limited to:

• Provides support for local laboratory instrument computer systems including but not limited to:
  • System monitoring
  • Account management
  • Data-integrity support
  • Risk assessments
  • End-user support tasks
  • Tier 1 troubleshooting
  • Regulatory audit SME
  • System Owner Support

• Cross trains to provide administrative support for laboratory Enterprise databases (including but not limited to, SmartQC, GQCLIMS, Empower, Electronic Lab Notebook):
  • Performs static data build for laboratory databases (Empower 3, GQCLIMS).
  • Maintains and troubleshoots laboratory databases.
  • Maintains change control related to laboratory databases.
  • Initiates/Participates in laboratory database related OCMs.
  • Performs account creation and maintenance.
  • End user support and troubleshooting.
  • Regulatory audit SME backup
  • Maintains instrument connectivity for chromatography systems that utilize Empower3 database.

• Author SOPs, work instruction and forms related to laboratory computerized systems, their usage, controls, and procedures. (local and enterprise lab systems)
• Collaborate with IT and System Owners to maintain system inventory information and Agile/Waterfall documentation.
• Serve as the primary link between local users and control/administration of computerized systems (primary for local and secondary for enterprise lab systems).
• Performs Tier 1 troubleshooting of local and enterprise lab systems, escalating issues to appropriate groups for further remediation if necessary. 
• Serves as an SME for laboratory systems (Local and enterprise)
• Performs systems related project work.
• Provides and follows up on ideas for continuous improvements in systems related laboratory processes
• May assist in investigations utilizing databases/systems (querying data, etc..)
• Interface effectively with customer groups: Quality Control Labs, Quality Assurance, Planning/Warehouse, Incoming Quality Control, GTC, Local IT, PET Quality/Batch Release in order to ensure that laboratory systems are meeting needs and capabilities are understood by stakeholders.
• Self-Directed.  Coordinates systems work with lab/site priorities and schedules.
• Self-Managed.  Able to complete tasks independently.
• Serves as on-site liaison for laboratory questions around use of local systems, answering what is in their scope and escalating to vendor or other support groups as necessary.

Education, Qualifications, Skills and Experience

• Bachelor’s Degree required, preferably in a science or technical field
• GMP experience required
• Quality Control Laboratory experience required

Preferred Background

• 5 years experience in GMP industry
• 3 years QC laboratory or IT experience
• High level of knowledge and competence with computers/computerized systems; able to translate analyst needs into computerized system setups.
• Experience with Empower Chromatography Data System
• Basic understanding of Data Integrity Principles
• Basic understanding of GAMP5 and Computer System Validation strategies
• Knowledge of SAP PM or equivalent

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.