_{16th June, 2025}

SUMMARY
Perform one or more of the following duties and responsibilities in support of  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.
 
Requirements:

• Doctorate OR -Masters + 2 years of directly related experience OR -Bachelors + 4 years of directly related experience OR -Associates + 8 years of directly related experience OR Educational background in Life Science and/or Engineering.
• 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.
•  Enhanced skills in leading, influencing and negotiating with the ability to interact with regulatory agencies and evaluate compliance issues.
• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish