Sr Associate QC Specialist

vor 4 Wochen

Bern, Schweiz Johnson & Johnson Vollzeit

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Control

Job Category:

Professional

All Job Posting Locations:

CH009 Janssen Vaccines AG, Bern

Job Description:Tasks
  • Organizes, coordinates and tracks maintenance workorders of approx. 500 lab equipment in SAP and on internal Sharepoint tools
  • Maintains the QC Labs equipment list in internal Sharepoint
  • Creates and tracks equipment related notifications and tickets in Maximo system
  • Maintains the list of the maintenance planner in internal Sharepoint
  • Records and actively monitors work-order related KPIs
  • Places orders on behalf of QCSE and QC Lab teams (in SAP, eMarketplace, Arriba)
  • Support in archiving of documents related to his(her) own area of responsibility
  • Able to operate the autoclave, washing machine and hot air sterilizer in the washkitchen, when and if required
  • Performs incoming inspection and distribution of samples in the sample receiving area including booking of samples in SAP/e-LIMS if required
  • Acts as Lab Administrator for computerized systems within QC
  • Executes and/or supports equipment lifecycle activities such as periodic reviews (access, Audit Trail), calibration and maintenance tasks
  • Able to execute equipment/system qualification, validation and decommissioning activities, through Change Control procedures, within the QC department (e.g. clarification with vendors and the QC testing labs, writing technical documents) including collaboration with interdepartmental stakeholders, when and if required
  • Able to support (improvement) projects regarding equipment and automated systems within the QC labs department
  • Able to support timely and effective completion of equipment related investigations, change controls and CAPA’s related to equipment activities
Profile
  • University degree in natural sciences, applied sciences or equivalent professional working experience
  • At least 5 years of relevant working experience
  • Good understanding of analytical technologies, GMP experience is a plus.
  • Know-how about maintenance concept and processes for Laboratory Equipment
  • Know-how about commissioning, qualification and computer system validation requirements in a laboratory environment is a plus
  • Must be well organized, a self-starter, results oriented individual with the ability to multitask in a fast-paced team environment with attention to detail and good documentation practice
  • Strong strategic and conceptual skills, analytical thinking and problem-solving ability
  • Proactive attitude, team player, team builder
  • Good verbal and written skills in English and German
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