Validation Specialist

3 weeks ago


Gainesville, Florida, United States Ascend Advanced Therapies Full time
Job Summary:

We are seeking a skilled Validation Specialist to join our team at Ascend Advanced Therapies. As a key member of our regulatory compliance department, you will be responsible for ensuring the validation of equipment and computer systems meets the highest standards.

This role is ideal for individuals with a strong understanding of cGMP and GDP regulations. You will work closely with multiple departments to provide validation support, interact with technical teams, and ensure site compliance.

The successful candidate will have excellent time management and prioritization skills, with the ability to work independently and as part of a team. Strong written and verbal communication skills are essential, along with a working knowledge of Microsoft Office applications.

Key Responsibilities:

  • Develop specifications for user requirements, functional requirements, design requirements, trace matrices, validation summary reports, and test protocols
  • Analyze validation test data to determine whether equipment and systems meet validation acceptance criteria or identify potential root causes of problems
  • Conduct all work according to governing policies, Validation Master Plans, SOPs, industry standards, and governing regulations/cGMPs

Benefits:

  • Annual bonus up to $10,000 based on performance
  • 401k matching up to 3% and additional insurances
  • 20 days PTO, 5 days Sick leave, and 6 weeks Parental Leave

About Ascend:

At Ascend Advanced Therapies, we are pioneers in the future of healthcare through relentless innovation. Our mission is to manufacture safe, efficacious, and scalable gene therapies. We value quality by integrity, adaptability, and serving patients by serving our partners.

Estimated Salary:$110,000 - $130,000 per year, depending on experience.


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