Website genentech Genentech

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity. We believe every employee makes a difference. We are passionate about transforming patients’ lives. We are courageous in both decision and action, we believe that good business means a better world.

 

The focus of Hillsboro Technical Operations (HTO) is Drug Product manufacturing (Component Prep & Compounding, Liquid/Lyophilized Filling, Automated/Manual Inspection, Packaging/Finished Products and Distribution).   The site is currently transitioning to SingleLIMS, an upgraded network wide Laboratory Information Management System (LIMS).  The focus of this position will be to support the deployment and maintenance of the Master Data for this upgraded system.

 

Shift:  Day Shift (times flexible), Monday to Friday

Type: Contingent, 1 year contract with possible extension to 3 years based on need

Work Environment: On-site.  Some remote work available with advanced approval by the manager

Responsibilities:

Primary:

·       Work with the site LIMS Data Manager to create/update/test master data to enable tracking, testing, and reporting of environmental monitoring samples, product testing samples, raw material testing samples, and cleaning validation/verification samples.

·       Work with site Data Manager to create / update procedures using the Roche electronic Document Management System (Veeva Vault QualityDocs) for maintaining SingleLIMS Master Data

·       Participate in the deployment of SingleLIMS (upgraded network wide LIMS) at HTO

·       Coordinate SingleLIMS end user training / roadshows

·       Support the evaluation/investigation of master data related unplanned events using (Veeva Vault QMS)

·       Maintain laboratory instrument user accounts and configuration settings

·       Execute various administrative tasks (e.g.:  manage the flow of documents (electronic and physical) related to ASAT activities, compile/file data packages (validation, certificate of analysis), issue laboratory logbooks)

·       Complete training curriculums, as assigned

·       May request/review equipment, material, and recipe master data creation/changes in SAP

·       May compile/complete various periodic reviews  (e.g.: alarm monitoring reviews, annual user account audits, quality metrics reporting, annual product quality reviews)

·       May perform review of analytical results to support generation of product certificates of analysis

 

Qualifications:

·       Associates or Vocational Degree or a High School Diploma with at least 3 years of work experience in similar roles

·       Strong PC skills; experience using Google Collaboration Tools (e.g.: gMail, gSheets, gDocs, gDrive, gChat) is a plus.

·       Ability to enter data into a computerized system for long periods of time

·       Ability / knowledge about working in regulated industry;  direct GMP experience is a plus.

·       Ability to work independently and collaboratively and in a hybrid team environment

·       Experience with SAP, LIMS, Database management, or Master Data a plus

·       If required, you’ll be asked to provide proof that you’re fully vaccinated upon your start date

To apply for this job please visit careers.gene.com.