Specialist Quality Assurance

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

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.

Qualifications:

• Bachelor's degree and 5 years of directly related experience
• Experience in batch record review, DAI process and to be familiar with in PASx/MES application, MAXIMO, SAP and LIMS.
• Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
• In addition, some knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP and LIMS.
• Available for non standard shift which includes nights and weekends (Shift: 12 hrs
  5a-5:30p or 5pm-5:30am)
• Validation and process development KNOWLEDGE