Regulatory Compliance Specialist
1 settimana fa
At Danaher Corporation, we are seeking a highly motivated and detail-oriented Laboratory Compliance Associate to join our team. As a key member of our Laboratory Compliance, Maintenance, and Safety team, you will be responsible for ensuring the manufacturing and quality control labs are compliant with regulatory guidelines and company policies.
Key Responsibilities- Compliance and Quality Control: Implement GMP and GLP practices/procedures and serve as a functional expert in the area of lab compliance.
- Lab Inspections and Audits: Perform regular lab inspections & audits (i.e., Manufacturing and QC) to ensure adherence to company policies, guidelines, SOPs, and Biosafety program.
- Reporting and Analysis: Analyze and report lab inspections & audits to appropriate management and follow up on corrective and preventive actions.
- Contamination Surveillance: Maintain laboratory contamination surveillance and decontamination program to ensure amplicons and other ANA (Amplifiable Nucleic Acids) contamination are prevented.
- Education and Experience: Bachelor's degree with 0-2 years of related work experience OR 5 years of related work experience.
- Knowledge and Skills: Knowledge and/or hands-on experience with GMP test sample collection and sampling.
- Work Environment: 24/7 production and laboratory working environment, including modified shift times, overtime, and weekends.
- Standards and Regulations: Must be able to follow cGMP, GLP, FDA, and ISO standards.
- Interpersonal Skills: Excels in a fast-paced team environment, is able to multi-task, is highly self-motivated, and is goal-oriented.
At Danaher Corporation, we offer a competitive salary range of $59,900-$81,800 and the opportunity to work in a dynamic and supportive environment. This role is also eligible for bonus/incentive pay.
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Quality Systems Specialist I
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Lodi, Lombardia, Italia Danaher Corporation A tempo pienoJob SummaryWe are seeking a highly skilled Quality Systems Specialist to join our team at Danaher Corporation. As a Quality Systems Specialist, you will be responsible for reviewing records to ensure compliance with regulatory requirements and making recommendations for improvement.Key ResponsibilitiesReview records and documents for completeness and...
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Lodi, Lombardia, Italia Danaher Corporation A tempo pienoQuality Systems Specialist I Job DescriptionAt Danaher Corporation, we are committed to delivering high-quality products and services that meet the needs of our customers. We are seeking a highly skilled Quality Systems Specialist I to join our team.Key Responsibilities:Review records and documents to ensure compliance with QSR and ISO requirements.Develop...
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Lodi, Lombardia, Italia Danaher Corporation A tempo pienoJob SummaryAt Danaher Corporation, we are seeking a highly motivated and detail-oriented Laboratory Compliance Associate to join our team. As a key member of our Laboratory Compliance, Maintenance, and Safety team, you will be responsible for ensuring the manufacturing and quality control labs adhere to regulatory guidelines and company policies.Key...
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Lodi, Lombardia, Italia Danaher Corporation A tempo pienoJob DescriptionJob Title: Quality Systems Specialist IJob Summary:We are seeking a highly motivated and detail-oriented Quality Systems Specialist I to join our team at Danaher Corporation. As a Quality Systems Specialist I, you will play a critical role in ensuring the quality of our products and processes.Key Responsibilities:Collaborate with Manufacturing...
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