Regulatory Compliance Specialist

6 days ago


San Antonio, Texas, United States Katalyst Healthcares and Life Sciences Full time

About the Role:

Katalyst Healthcares and Life Sciences is seeking a highly skilled Validation Specialist to join our team. As a Validation Specialist, you will be responsible for ensuring the quality and integrity of our products by validating processes and equipment.

Key Responsibilities:

  • Process Validation: Develop and execute process validation protocols to ensure the quality and consistency of our products.
  • Equipment Validation: Validate equipment and systems to ensure they meet regulatory requirements and are functioning correctly.
  • Documentation and Reporting: Create and maintain accurate and detailed documentation of validation activities, including protocols, reports, and records.
  • Collaboration and Communication: Work closely with cross-functional teams, including engineering, quality, and operations, to ensure seamless execution of validation activities.
  • Regulatory Compliance: Ensure that all validation activities are conducted in accordance with relevant regulatory requirements, including FDA and cGMP regulations.

Requirements:

  • Education: Bachelor's degree in Engineering, Science, or equivalent technical degree.
  • Experience: 3-5+ years of experience in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
  • Skills: Excellent written and verbal communication skills, strong interpersonal skills, and ability to work in a team environment.
  • Technical Skills: Proficient in Microsoft Word, Excel, and PowerPoint, and experience with statistical tools and software, such as MiniTab.


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