Specialist QA 35269- Quality System & Validations

CIS International LLC

  • Juncos, PR
  • Autónomo
  • Tiempo completo
  • Hace 6 días
SUMMARY:
Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.FUNCTIONS: * Review and approve product MPs.
  • Approve process validation protocols and reports for manufacturing processes.
  • Request Quality on incident triage team.
  • Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Lead site audits.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.
  • Review Risk Assessments.
  • Support Automation activities.
  • Support facilities and environmental programs.
  • Review and approve Work Orders.
  • Review and approve EMS/BMS alarms.
  • Approve NC investigations and CAPA records.
  • Approve change controls.
  • Provide lot disposition and authorize lots for shipment.
EDUCATION:
  • Doctorate or Masters + 2 years of experience.
  • Bachelors + 4 years of experience.
  • Associates + 8 years of experience.
  • High school/GED + 10 years of experience.
  • Experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation.
PREFERRED QUALIFICATIONS:
  • Quality Professional with experience in Quality System and Validations. In addition, some knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva. Available during weekends and holidays as requested, always available to be on site. Amgen processes experience is preferred.
SKILLS:
  • Project management skills.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Initiate and lead cross functional teams.
  • Enhanced skills in leading, influencing and negotiating.
  • Strong knowledge in area of expertise.
  • Collaborate and coordinate with higher level outside resources.
  • Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
  • Demonstrate ability to interact with regulatory agencies.
  • Strong word processing, presentation, database and spreadsheet application skills.
  • Strong communication (both written and oral), facilitation and presentation skills.
  • Strong skill in working independently and to effectively interact with various levels.
  • Advanced data trending and evaluation.
  • Ability to evaluate compliance issues.
  • Demonstrate the Amgen Values/Leadership Practices.
WORK METHODOLOGY:
  • Full on site job in Juncos, PR
  • Full time job
  • Expected project duration: 12 months for the first contract, with a high possibility of extension based on performance and budget.
  • Administrative Shift (weekends and overtime may also be required).
  • Expected hiring date: May 2026

CIS International LLC