Quality Assurance Technical Leader
2 weeks ago
The Quality Assurance Technical Leader is tasked with overseeing the client's Quality Management Systems, including Documentation, Deviations, CAPA, Change Control, Self-Inspections, and Risk Management to ensure they are effectively implemented and adhered to.
Key Responsibilities:
- Engage in preparation for inspections, support during regulatory audits, and conduct self-inspection activities.
- Analyze quality system metrics and trends.
- Collaborate across departments with management within and beyond Technical Operations to guarantee uniform application of quality systems.
- Contribute to initiatives aimed at enhancing quality systems and process mapping.
- Draft and maintain site-specific Quality Technical Agreements.
- Bachelor’s or Master’s degree, preferably in a life sciences discipline.
- Over 6 years of experience in the pharmaceutical sector or a related field.
- Proven understanding of cGMPs, Health Authority Regulations, Quality Systems, and technical knowledge in manufacturing processes.
- Capability to interpret technical documentation related to analytical techniques, manufacturing processes, and regulatory standards.
- Knowledge of FDA, European, and international regulatory guidelines.
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Quality Assurance Technical Manager
2 weeks ago
Novato, California, United States Harvest Technical Services, Inc. Full timeJob OverviewCompany Overview: Harvest Technical Services, Inc. is a pioneering organization dedicated to providing innovative therapeutics for patients facing serious and life-threatening rare genetic disorders. Our focus is on conditions that currently lack effective treatment options, particularly those affecting children.Role Summary: The Quality...
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Quality Assurance Technical Manager
2 weeks ago
Novato, California, United States Harvest Technical Services Full timeCompany OverviewHarvest Technical Services is a leading organization dedicated to developing innovative therapeutics aimed at addressing serious and life-threatening rare genetic disorders. Our focus is on conditions that currently lack effective treatment options, often impacting small patient populations, including children.Role SummaryThe Quality Systems...
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Quality Assurance Technical Leader
1 week ago
Novato, California, United States Randstad North America, Inc. Full timeKey ResponsibilitiesInspection Readiness: Engage in activities that ensure preparedness for inspections, including regulatory and self-inspection processes.Quality System Metrics: Analyze and report on quality system metrics, focusing on trends and performance indicators.Cross-Functional Collaboration: Collaborate effectively with management across various...
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Operations Quality Assurance Specialist
5 days ago
Novato, California, United States Harvest Technical Services, Inc. Full timeJob SummaryHarvest Technical Services, Inc. is seeking a highly skilled Operations Quality Assurance Specialist to join our team. As a key member of our operations department, you will be responsible for providing quality oversight of various aspects of our operations.Key Responsibilities:Review and verify GMP documentation from manufacturing, including...
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Technical Quality Assurance Manager
2 weeks ago
Novato, California, United States Biomarin Full timeAbout UsAt BioMarin, our Technical Operations team is dedicated to the development and production of our innovative therapies for clinical trials and commercial distribution. Our skilled engineers, technicians, scientists, and support personnel are committed to establishing and maintaining BioMarin's advanced manufacturing processes and facilities. They...
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Technical Manager for Quality Assurance
2 weeks ago
Novato, California, United States TalentBurst Full timePosition: Technical Manager, Quality Systems Overview TalentBurst is a leader in the development of innovative therapies aimed at addressing serious and life-threatening rare genetic disorders. Our mission is to target conditions that currently lack effective treatment options, impacting small patient populations, including children. We are committed to...
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Quality Assurance Technical Manager
2 weeks ago
Novato, California, United States TalentBurst Full timePosition: Technical Manager, Quality Systems Company Overview TalentBurst is a leader in providing innovative solutions for patients facing serious and rare genetic conditions. Our mission is to develop effective therapies for diseases that currently have limited treatment options, focusing on improving the lives of those affected, especially children. Role...
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Operations Quality Assurance Specialist
4 days ago
Novato, California, United States Harvest Technical Services, Inc. Full timeJob SummaryHarvest Technical Services, Inc. is seeking a highly skilled Operations Quality Assurance Specialist to join our team. As a key member of our operations department, you will be responsible for providing quality oversight of various aspects of our operations.Key ResponsibilitiesQuality Oversight: Review and ensure adherence to company policies,...
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Quality Technical Manager
1 month ago
Novato, California, United States BioMarin Pharmaceutical Inc. Full timeWho We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality...
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Quality Systems Assurance Lead
2 weeks ago
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Quality Assurance Specialist
5 days ago
Novato, California, United States BioMarin Full timeAbout the RoleBioMarin is seeking a highly skilled Quality Assurance Specialist to join our Technical Operations team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesCreate and/or revise product specification documents, following regulatory guidelines and industry...
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Quality Assurance Manufacturing Lead
2 weeks ago
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Manager of Quality Assurance Processes
2 weeks ago
Novato, California, United States TalentBurst, an Inc 5000 company Full timeQuality Assurance Systems ManagerCompany: TalentBurst, an Inc 5000 companyRole OverviewThe Quality Assurance Systems Manager plays a crucial role in overseeing the adherence to quality management systems within the organization. This position is pivotal in ensuring that all quality-related processes, including Documentation, Deviation Management, CAPA,...
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Quality Assurance Specialist
1 week ago
Novato, California, United States Innova Solutions Full timeInnova Solutions is seeking a highly skilled Quality Assurance Specialist to join our team.Job Summary:We are looking for a detail-oriented and organized individual to provide quality oversight of our operations. As a Quality Assurance Specialist, you will be responsible for ensuring that our manufacturing processes meet the highest standards of quality and...
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Quality Assurance Specialist
2 weeks ago
Novato, California, United States OMW Corporation Full timePosition: Quality Assurance SpecialistCompany OverviewOMW Corporation is a premier contract manufacturing firm specializing in the precise machining of custom metal and plastic components for leading sectors such as aerospace, electronics, and healthcare. Recognized for its rapid growth and innovation, OMW is on the lookout for talented individuals who...
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Quality Assurance Specialist
3 days ago
Novato, California, United States TalentBurst, an Inc 5000 company Full timeJob Summary:TalentBurst, an Inc 5000 company, is seeking a highly detail-oriented Quality Assurance Specialist to join our team. As a key member of our operations team, you will be responsible for providing quality oversight of various aspects of our operations.Key Responsibilities:Review and Verification: Conduct thorough reviews of GMP documentation,...
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Quality Assurance Specialist
2 days ago
Novato, California, United States BioMarin Full time**About BioMarin**BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and...
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Quality Assurance Specialist
1 day ago
Novato, California, United States TalentBurst, an Inc 5000 company Full timeJob Summary:TalentBurst, an Inc 5000 company, is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for providing quality oversight of one or more processes relating to the production of products in our manufacturing facilities.Key Responsibilities:Provide quality oversight of one or more...
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Quality Assurance Operations Specialist
5 hours ago
Novato, California, United States Randstad Full timeJob Summary:We are seeking a highly skilled Quality Assurance Operations Specialist to join our team at Randstad. As a Quality Assurance Operations Specialist, you will be responsible for providing quality oversight of operations, including reviewing GMP documentation, scanning and archiving production batch records, and ensuring manufacturing adherence to...
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Quality Assurance Operations Analyst
2 weeks ago
Novato, California, United States Compass Consulting Full timeAbout Us: Compass Consulting is dedicated to advancing healthcare solutions through innovative therapeutics aimed at addressing serious and life-threatening rare genetic disorders.Position Overview:This role, reporting to the Quality Assurance Supervisor/Manager/Senior Manager, is pivotal in ensuring quality compliance across various processes involved in...