- 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.
- Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.
- 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.
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Specialist QA
hace 1 semana
QRC Group, LLC Juncos, Puerto RicoSpecialist QA with experience in regulated industries to:Perform Trackwise system queries, deviations · Participate in triage process · Perform oversight of the process and procedures/GMP tasks · Manage Change Controls and deviations for review and approval as QA contact · Work w ...
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Specialist Qa
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Qrc Group, Llc Juncos, Puerto RicoJob Description Specialist QA with experience in: Aseptic Technics Change Control New Product Introduction Requirements Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience (Education: Scien ...
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Specialist QA
hace 1 semana
QRC Group, Inc Juncos, Puerto RicoJob Description · Specialist QA with experience in regulated industries to: · Perform Trackwise system queries, deviations · Participate in triage process · Perform oversight of the process and procedures/GMP tasks · Manage Change Controls and deviations for review and approval a ...
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Specialist QA
hace 1 semana
QRC Group, LLC Juncos, Puerto RicoJob Description · Specialist QA with experience in regulated industries to:Perform Trackwise system queries, deviations · Participate in triage process · Perform oversight of the process and procedures/GMP tasks · Manage Change Controls and deviations for review and approval as Q ...
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Specialist Qa
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Qrc Group Llc Juncos, Puerto RicoSpecialist QA with experience in: Aseptic Technics Change ControlNew Product IntroductionRequisitos:Doctorate degree or Master's degree and 3 years of directly related experience orBachelor's degree and 5 years of directly related experience (Education: Science or Engineering)Bil ...
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Specialist Manufacturing
hace 1 día
MyKelly Juncos, Puerto Rico De jornada completaKelly Engineering is seeking Specialist Manufacturing for a 12 month contract position at a Global Pharmaceutical & Biotechnology client in Juncos, Puerto Rico. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in yo ...
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Specialist QA
hace 1 día
MyKelly Juncos, Puerto Rico De jornada completaKelly Science & Clinical is seeking Specialist QA for contract position at Pharmaceutical client in Puerto Rico East area. · FUNCTIONS · - Review and approve product MPs. · - Approve process validation protocols and reports for manufacturing processes. - Request Quality on incid ...
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Specialist Qa
hace 1 semana
Qrc Group Llc Juncos, Puerto RicoSpecialist QA with experience in regulated industries to:Perform Trackwise system queries, deviationsParticipate in triage processPerform oversight of the process and procedures/GMP tasksManage Change Controls and deviations for review and approval as QA contactWork with operatio ...
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Specialist Manufacturing
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Integrated Services For Productivity & Validation, Inc Juncos, Puerto RicoProject need expertise required;Procedure development · Change Control · CAPA · Deviation · Risk Assessment · Requirements · Shift, Education & years of experience needed;Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience · OR Bachelor's degre ...
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Specialist Manufacturing
hace 1 día
Integrated Services For Productivity & Validation, Inc Juncos, Puerto RicoJob Description · Project need expertise required;Procedure development · Change Control · CAPA · Deviation · Risk Assessment · Requirements · Shift, Education & years of experience needed;Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience · O ...
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QA Specialist
hace 5 días
Integrated Services For Productivity & Validation, Inc Juncos, Puerto RicoExpertise required: · Aseptic Techniques, Change Control and New Product Introduction. · Requirements · Education and years of experience requirements; · Doctorate degree or Master's degree and 3 years of directly related experience · or Bachelor's degree and 5 years of directly ...
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Specialist QA
hace 1 semana
Integrated Services For Productivity & Validation, Inc Juncos, Puerto RicoCandidates qualifications / expertise; · • Perform Trackwise system queries, deviations · • Participate in triage process · • Perform oversight of the process and procedures/GMP tasks · • Manage Change Controls and deviations for review and approval as QA contact · • Work with op ...
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Specialist QA
hace 5 días
Integrated Services For Productivity & Validation, Inc Juncos, Puerto RicoJob Description · Candidates qualifications / expertise; · • Perform Trackwise system queries, deviations · • Participate in triage process · • Perform oversight of the process and procedures/GMP tasks · • Manage Change Controls and deviations for review and approval as QA contac ...
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Specialist QA
hace 1 día
Mirus Consulting Group Juncos, Puerto Ricomirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services inclu ...
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QA Specialist
hace 1 semana
Integrated Services For Productivity & Validation, Inc Juncos, Puerto RicoJob Description · Expertise required: · Aseptic Techniques, Change Control and New Product Introduction. · Requirements · Education and years of experience requirements; · Doctorate degree or Master's degree and 3 years of directly related experience · or Bachelor's degree and 5 ...
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Specialist Qa
hace 4 días
Cis International Llc Juncos, Puerto RicoFunctions: - 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 incident ...
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Specialist Qa
hace 6 días
Flexible & Integrated Technical Services, Llc Juncos, Puerto RicoFor Quality services in the Quality Assurance area WHAT MAKES YOU A FIT: The Technical Part: Bachelor's Degree with five (5) years of directly experience as Quality Professional in the regulated industry. Bilingual (English & Spanish) Project Management skills Shift: Administrati ...
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Qa Specialist
hace 1 semana
Professional Pharma Solutions Juncos, Puerto RicoPerform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.Requisitos:Preferred Qualifications: · • Perform Trackwise system queries, deviations · • Participate in triage process · • Perform oversight of the ...
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Specialist QA
hace 1 semana
Integrated Services For Productivity & Validation, Inc Juncos, Puerto RicoQualified candidates please review the required expertise; · • Perform Trackwise system queries, deviations · • Participate in triage process · • Perform oversight of the process and procedures/GMP tasks · • Manage Change Controls and deviations for review and approval as QA cont ...
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Engineering Specialist
hace 5 días
Weil Group, Inc Juncos, Puerto Rico· Minimum Requirements · Mid-level individual contributor on a project or work team, 3-5 years of experience required. · Bachelor Degree in Engineering · Experience within Medical Devices and/or Pharmaceutical industries. · Experience in equipment IQ, OQ and PQ, Validation, CSV ...
Specialist QA - Juncos, Puerto Rico - Weil Group, Inc
Descripción
SUMMARY
Perform one or more of the following duties and responsibilities in support of Client's Quality Assurance program under minimal supervision.
FUNCTIONS
EDUCATION/LICENSES
COMPETENCIES/SKILLS