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.
Demonstrate ability to interact with regulatory agencies.
Approve NC investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Qualifications: Bachelor's degree in Sciences or Engineering 5 years of directly related experience Quality Professional with Manufacturing Process Audit and Batch Record Review experience.
Knowledge or to be familiar with DAI process, PASx/MES application, MAXIMO, SAP and LIMS. Advanced data trending and evaluation.
Ability to evaluate compliance issues.
Able to perform review, approval and tracking of cGMP processes, procedures, testing (methods) in manufacturing, documents and records, batch record review, MES, EBR, SAP, Trackwise; including but not limited to Deviation's, CAPAs, and validations.
Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
Project management skills Available for non standard shift which includes nights and weekends.
5am to 530pm or from 5pm to 530am Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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