Validation & Engineering Group, Inc.
Summary
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Responsibilities
Approve process validation protocols and reports for Quality Control and Information Systems.
Request quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Represent QA.
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 Deviation investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Review and approve test run in Application Lifecycle Management (ALM).
Review and approve Systems documents.
Education / Licenses 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
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.
Available to work extended hours, possibility of weekends and holidays.
Fully bilingual - English and Spanish
Seniority level Mid‑Senior level
Employment type Contract
Job function Strategy/Planning and Information Technology
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Responsibilities
Approve process validation protocols and reports for Quality Control and Information Systems.
Request quality on incident triage team.
Approve Environmental Characterization reports.
Release of sanitary utility systems.
Represent QA.
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 Deviation investigations and CAPA records.
Approve change controls.
Provide lot disposition and authorize lots for shipment.
Review and approve test run in Application Lifecycle Management (ALM).
Review and approve Systems documents.
Education / Licenses 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
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.
Available to work extended hours, possibility of weekends and holidays.
Fully bilingual - English and Spanish
Seniority level Mid‑Senior level
Employment type Contract
Job function Strategy/Planning and Information Technology
#J-18808-Ljbffr