Regulated Industry Quality Expert

3 weeks ago


Elkhorn City, Kentucky, United States Merck Full time
About the Job

Join Merck, a leading research-driven pharmaceutical products and services company, as a Regulated Industry Quality Expert and contribute to improving human health around the world. Estimated Salary: $90,000 - $120,000 per year.

In this role, you will have the opportunity to work collaboratively with other talented colleagues to pursue and bring hope to countless people battling the most challenging diseases of our time. As a Regulated Industry Quality Expert, you will be responsible for ensuring the quality of our packaging operations, adhering to local and global Animal Health standards, USDA regulations, and cGMP generally.

Key Responsibilities:
  • Support the development and implementation of quality management systems.
  • Conduct audits, investigations, and risk assessments to ensure compliance with regulatory requirements and company policies.
  • Develop and maintain SOPs related to packaging operations.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company policies.
  • Participate in quality inspections and audits.

Requirements:

  • Minimum 2 years of quality experience in a regulated industry.
  • Strong communication and technical writing skills.
  • Experience with investigations, risk assessment, and regulatory inspections.
  • Skilled in technical writing and familiar with QMS like SAP, Trackwise, and Reliance or similar quality system.


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