We have other current jobs related to this field that you can find below
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Pharmaceutical QA Specialist
2 weeks ago
El Segundo, United States Fladger Associates Full timeResponsibilities:Excellent employment opportunity for a QA Specialist – III in the El Segundo, CA area.Role is fully Onsite- 5 days a week.This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.Report in to the Sr. QA Manager, Quality Operations.Review batch-related...
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QA Specialist – III
2 weeks ago
El Segundo, United States Fladger Associates Full timeResponsibilities:Excellent employment opportunity for a QA Specialist – III in the El Segundo, CA area.Role is fully Onsite- 5 days a week.This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.Report in to the Sr. QA Manager, Quality Operations.Review batch-related...
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QA Specialist/ Quality Assurance Specialist
2 weeks ago
El Segundo, United States Infotree Global Solutions Full timeNo H1B and/or C2C Please!!No Software QA Please!!One of our leading Pharmaceutical client is looking for a QA Specialist/ Quality Assurance Specialist (Pharma/Biotech), who will be responsible for participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.Job Title: QA Specialist/ Quality Assurance...
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QA Specialist/ Quality Assurance Specialist
2 weeks ago
El Segundo, United States Infotree Global Solutions Full timeNo H1B and/or C2C Please!!No Software QA Please!!One of our leading Pharmaceutical client is looking for a QA Specialist/ Quality Assurance Specialist (Pharma/Biotech), who will be responsible for participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.Job Title: QA Specialist/ Quality Assurance...
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Senior QA Tester
1 month ago
El Segundo, United States Nexon America Inc Full timeJob DescriptionJob DescriptionAbout NexonNexon America is a branch of Nexon Co., Ltd., a global video game publisher and leading developer of online virtual worlds for PCs, consoles, and mobile devices. Nexon proudly offers celebrated franchises like MapleStory, KartRider, and Mabinogi that have been enjoyed by millions of players for over two decades. When...
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Senior QA Tester
1 month ago
El Segundo, United States NEXON Full timeAbout Nexon Nexon America is a branch of Nexon Co., Ltd., a global video game publisher and leading developer of online virtual worlds for PCs, consoles, and mobile devices. Nexon proudly offers celebrated franchises like MapleStory, KartRider, and Mabinogi that have been enjoyed by millions of players for over two decades. When we founded our Nexon America...
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Senior Quality Assurance Specialist
2 weeks ago
El Segundo, United States Integrated Resources, Inc ( IRI ) Full timeJob Title: QA Specialist - IIILocation: El Segundo, CADuration: 06+ MonthsRole is fully Onsite- 5 days a week.Responsibilities• Review batch-related documentation and ensure resolution of issues to release product.• Perform comprehensive quality review of batches for disposition.• Ensure process control measures are in place and followed in product...
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Senior Quality Assurance Specialist
2 weeks ago
El Segundo, United States Integrated Resources, Inc ( IRI ) Full timeJob Title: QA Specialist - IIILocation: El Segundo, CADuration: 06+ MonthsRole is fully Onsite- 5 days a week.Responsibilities• Review batch-related documentation and ensure resolution of issues to release product.• Perform comprehensive quality review of batches for disposition.• Ensure process control measures are in place and followed in product...
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Quality Assurance Specialist
3 months ago
El Segundo, United States LanceSoft, Inc. Full timeJob Details: We are seeking a Senior Specialist of Quality Operations responsible for Product Disposition. This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. NOTE: Position is Day Shift including weekends and requires onsite presence. Basic Qualifications • Master’s...
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Quality Assurance Specialist
3 months ago
El Segundo, United States LanceSoft, Inc. Full timeJob Details: We are seeking a Senior Specialist of Quality Operations responsible for Product Disposition. This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. NOTE: Position is Day Shift including weekends and requires onsite presence. Basic Qualifications • Master’s...
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Quality Assurance Operations Specialist
6 days ago
El Segundo, California, United States LanceSoft, Inc. Full timePosition Overview:We are looking for a Senior Quality Operations Specialist to oversee Product Disposition. This role is crucial in participating in Quality initiatives to guarantee adherence to relevant quality standards and regulatory obligations.Work Schedule:This position operates on a Day Shift, including weekends, and necessitates an onsite...
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Quality Assurance Operations Specialist
22 hours ago
El Segundo, California, United States LanceSoft, Inc. Full timePosition Overview:We are looking for a dedicated Senior Specialist in Quality Operations focused on Product Disposition. This role is essential in participating in Quality initiatives to guarantee adherence to relevant quality standards and regulatory obligations.Work Schedule: This is a Day Shift position that includes weekends and necessitates onsite...
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Quality Assurance Operations Specialist
23 hours ago
El Segundo, California, United States LanceSoft, Inc. Full timePosition Overview:We are looking for a Senior Quality Operations Specialist focused on Product Disposition. This role is crucial in participating in Quality initiatives to ensure adherence to relevant quality objectives and regulatory standards.Work Schedule: This position operates on a Day Shift, including weekends, and necessitates an onsite...
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Quality Assurance Operations Specialist
1 day ago
El Segundo, California, United States LanceSoft, Inc. Full timePosition Overview:We are looking for a Senior Quality Operations Specialist focused on Product Disposition. This role is crucial in participating in Quality initiatives to ensure adherence to relevant quality standards and regulatory obligations.Work Schedule: This position operates on a Day Shift, including weekends, and necessitates onsite...
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Quality Assurance Operations Specialist
23 hours ago
El Segundo, California, United States LanceSoft, Inc. Full timePosition Overview:We are looking for a Senior Quality Assurance Specialist focused on Quality Operations, particularly in Product Disposition. This role involves engaging in Quality initiatives to ensure adherence to relevant quality standards and regulatory guidelines.Work Schedule: This is a Day Shift position that includes weekends and necessitates onsite...
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Quality Assurance Specialist
2 weeks ago
El Segundo, United States ATR International Full timeWe are seeking a QA Specialist - III for a very important client.Responsibilities• Review batch-related documentation and ensure resolution of issues to release product.• Perform comprehensive quality review of batches for disposition.• Ensure process control measures are in place and followed in product manufacturing• Ensure all product-related...
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Quality Assurance Specialist
2 weeks ago
El Segundo, United States ATR International Full timeWe are seeking a QA Specialist - III for a very important client.Responsibilities• Review batch-related documentation and ensure resolution of issues to release product.• Perform comprehensive quality review of batches for disposition.• Ensure process control measures are in place and followed in product manufacturing• Ensure all product-related...
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Quality Assurance Specialist
2 weeks ago
El Segundo, United States ACL Digital Full timeJob Title: QA Specialist - IIILocation: El Segundo, CADuration: 06 MonthsDescription:Role is fully Onsite- 5 days a week.This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position is located at our El Segundo, CA site and report into the Sr. QA Manager, Quality...
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Quality Assurance Specialist
2 weeks ago
El Segundo, United States eTeam Full timeRole: QA Specialist - III*Term: 6 month contractSchedule: 5 days onsite - El Segundo, CARate: $40/hr - $50 per hour on W2 This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position is located at our El Segundo, CA site and report into the Sr. QA Manager, Quality...
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Quality Assurance Specialist
2 weeks ago
El Segundo, United States eTeam Full timeRole: QA Specialist - III*Term: 6 month contractSchedule: 5 days onsite - El Segundo, CARate: $40/hr - $50 per hour on W2 This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position is located at our El Segundo, CA site and report into the Sr. QA Manager, Quality...
Senior Specialist, Clinical QA
2 months ago
Position Summary
The Senior Specialist, Clinical Quality ensures GCP compliance with companies entity standard operating procedures, ICH and US FDA regulations and guidelines, and clinical study protocols. This position interacts cross-functionally with functional teams in Clinical Trials which include Clinical Operations, Regulatory, Pharmacovigilance, Medical Writing and Data Management to ensure compliance to the GCP Quality Management System and all applicable regulatory requirements. This role is responsible for maintaining inspection readiness at all times.
Essential Functions
- Maintain and update the Clinical Trial Quality Management system to be current with industry standards, guidance, and best practices.
- Contributes to the development and review of SOPs and other controlled documents (forms, templates, work instructions).
- Ensures compliance with SOPs and ICH GCP E6 (R2) standards.
- Manages the incident management program through monitoring of complaints, deviations and CAPAs.
- Schedules, plans, coordinates, and conducts vendor/supplier audits, internal audits, compliance visits, for cause audits and clinical trial site audits.
- Prepares required documentation to support audit activities including audit plans, audit reports, audit certificates and corrective action plans
- Validates accuracy of audit findings, a written audit report and follow-up activities to assure that non-compliance issues are addressed with satisfactory resolution.
- Reviews the final audit documents for accuracy.
- Review trial related documents e.g. protocols, protocol amendments, ICFs, pharmacy manuals and CSRs
- Apply regulations, guidance document requirements, and study protocol requirements to clinical trial studies.
- Participate in solving GCP compliance issues within Quality Assurance, Clinical Operations, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
- Support joint efforts in training on company procedures, GCP regulations, and documentation systems to assure compliance with company policies and regulatory standards.
- Maintain all associated QA department spreadsheets tracking of deviations, CAPAs, complaints, audit findings, and audit files as applicable.
- Lead development and implementation efforts for inspection readiness at all times.
- Assists senior staff during regulatory inspections or other audits.
- Represents QA department at internal and external meetings supporting clinical programs.
- Performs other Quality related duties, as assigned.
Education & Experience
- Bachelor’s Degree in a life sciences or engineering discipline with a minimum of 7 years of experience in a GCP-Biologics or Pharmaceutical environment; or Master’s degree in a life sciences or engineering discipline with a minimum of 4 years’ of experience in a GCP-Biologics or Pharmaceutical environment.
- CQA or other audit certifications are a plus.
- Prior TMF or electronic document management systems experience is a plus.
