Specialist QA
Full time Remote @Confidential posted 1 day ago in Quality Assurance / Control Shortlist Email JobJob Detail
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Job ID 80821
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Career Level Officer
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Experience 8 Years +
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Gender Any
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Industry Recruitment
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Qualifications Master’s Degree
Job Description
SUMMARY
Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance 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.
EDUCATION/LICENSES
-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
-High school/GED + 10 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.
– Demonstrate the Client Values/Leadership Practices.
*Weil Group is proud to be an Equal Employment Opportunity Employer.*
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