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:

•  Responsible for 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 and site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities, facilities and environmental programs.
• Review and approve Work Orders, EMS/BMS alarms.
• Approve NC investigations, CAPA record and change controls.
• Provide lot disposition and authorize lots for shipment.

Qualifications:

•  Bachelor's degree in Life Science and/or Engineering.
• Five (5) years of directly related experience
• Expertise in Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
• Hands on experience in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements.
• Validated experience as Quality Contact for sophisticated projects involving new drug substance/products with experience in commissioning and qualifications