Regulatory Compliance Specialist

1 settimana fa


Lodi, Lombardia, Italia Danaher Corporation A tempo pieno
Job Summary

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.
Requirements
  • 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.
What We Offer

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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