- Specialist QA
- Shift: Mon/Tue then Fri/Sat/Sun on alternate weeks from 5:00 AM to 5:30 PM or from 5:00 PM to 5:30 AM.
- 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.
- 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.
- Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
- Knowledge or to be familiar with in PASx/MES application, MAXIMO, SAP and LIMS.
- Available for non-standard shift which includes nights and weekends. START YOUR APPLICATION
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MV01-101923 Specialist QA Non-Standard Shift - Juncos, Puerto Rico - Validation & Engineering Group, Inc
Descripción
Department: Field - FG Location: Juncos, JuncosSTART YOUR APPLICATION
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
Summary
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Functions
Education
Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience.
Competencies/Skills
Preferred Qualifications
