Quality Assurance Specialist
5 days ago
At Medix™, we are seeking a highly skilled Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities:- Document Management: Manage the initiation, revision, and distribution of documents in accordance with Good Documentation Practices (GDP) requirements.
- Quality Investigations: Assist in reviewing production records, testing records, and validation protocols to ensure product integrity and regulatory compliance.
- Materials Control: Oversee the control of critical and starting materials to ensure their quality and authenticity.
- Batch Record Management: Help compile and verify batch-related documents for product lot disposition.
- Deviation and CAPA Management: Support investigations of deviations, non-conforming materials, and CAPAs to ensure prompt resolution and corrective action.
- Quality Assurance Support: Provide Quality Assurance support for product and manufacturing issues to ensure compliance with regulatory requirements.
- Tracking and Closing: Assist with tracking and closing non-conformance and CAPA activities to ensure timely resolution.
- Validation and Audits: Participate in validation tasks and internal audits of the Quality Management System to ensure its effectiveness and efficiency.
- Equipment and Facility Reports: Review equipment, facility reports, and proposed system changes to ensure compliance with regulatory requirements.
- Education: Bachelor's Degree in life sciences or a related field.
- Knowledge and Skills: Knowledge of cGMP principles and FDA regulations, familiarity with aseptic processing and quality systems, strong communication, problem-solving, and teamwork skills.
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Quality Assurance Specialist
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Quality Assurance Specialist
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GMP Quality Assurance Specialist
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Quality Assurance Specialist
2 weeks ago
Rockville, Maryland, United States Medix™ Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Associate to support our document management, materials control, and compliance with Good Documentation Practices (GDP) and GMP standards.Key ResponsibilitiesDocument Management: Manage initiation, revision, and distribution of documents per GDP requirements.Quality Investigations: Assist in...
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Quality Assurance Specialist
1 week ago
Rockville, Maryland, United States Medix™ Full timeJob Summary:The Quality Assurance Associate will support the development and implementation of quality management systems, ensuring compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP) standards. This role will assist in quality investigations, validation tasks, and audits to ensure product integrity and regulatory...
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Quality Assurance Specialist
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Clinical Quality Assurance Specialist
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2 weeks ago
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Lead Quality Assurance Specialist
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Rockville, Maryland, United States Meso Scale Diagnostics LLC Full timeJob SummaryThe Lead Quality Auditor is a critical role within Meso Scale Diagnostics LLC, responsible for ensuring the company's quality systems and processes meet regulatory requirements. This position requires a strong background in auditing and quality assurance, with the ability to lead and mentor internal and external auditors.Key...
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Senior Quality Assurance Specialist
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Rockville, Maryland, United States Savantage Full timeSavantage Solutions: A Leader in Federal Systems and Oracle APEX SolutionsWe are seeking a highly skilled Senior Quality Assurance Tester to join our professional services team at Savantage Solutions. As a Senior QA Tester, you will play a critical role in ensuring the integrity, reliability, and performance of our software solutions tailored for federal...