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Specialist QA (Drug Substance)

Juncos, PR
Description / Responsibilities
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
Master’s degree in Sciences/Engineering and 3 years of Quality experience or Bachelor’s degree in Sciences/Engineering and 5 years of Quality experience.

Requirements
  • Experience in Quality Systems
  • Reviewing and approving deviation records, work orders, sanitization forms, documentation logbooks, and manufacturing processes and batch record.
  • Knowledge in critical utilities and biopharmaceutical facilities support.
  • Knowledge of electronic batch record, preferably (MES WERUM).
  • Self-started, express quality requirements in an effective and agile manner.
  • Knowledge in ERP and QMTS systems
  • Deviations
  • Investigations
  • CAPA
  • Change Control
  • Strong organizational skills
  • Available for Non-Standard shift (COVID-19 - 12hrs shifts, 8hrs shift/3 shifts)

Ultimate Solutions Corp is an equal opportunity employer.
 

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