Biotech Systems Specialist

2 days ago


New Albany, Ohio, United States AmplifyBio Full time
About Us

AmplifyBio is a leading contract research organization that provides a comprehensive range of services, from discovery stage R&D work to manufacturing services for cell, gene, and mRNA-based therapeutics.

The Opportunity

We are seeking an experienced Biotech Systems Specialist to join our Quality IT team in New Albany, OH. As a key member of our team, you will be responsible for ensuring the health, data integrity, and regulatory compliance of GxP computerized systems.

Job Responsibilities
  • Maintain and support the health of GxP computerized systems to ensure data integrity and regulatory compliance.
  • Develop and own technical SOPs and validation artifacts for new implementations or enhancements to existing systems.
  • Lead and manage computerized system validation activities to ensure effective requirements are captured and controls are in place to meet global regulatory requirements.
  • Perform and author data integrity and GxP risk assessments to identify areas for improvement.
  • Collaborate with various stakeholders to assess and select computerized systems that meet high-level business needs.
  • Drive resolution to technical issues, including audit and inspection related regulatory non-conformances.
Requirements

We are looking for a highly motivated and experienced professional with:

  • A minimum of 5 years' experience in GxP computer system validation, data integrity, and regulatory compliance in a pharmaceutical or biotech environment.
  • In-depth knowledge of regulations (FDA/EU/ICH), with emphasis on 21 CFR Part 11, 210, 211, 58, and 820.
  • Strong analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team.
  • Excellent communication and interpersonal skills, with the ability to interact effectively with internal and external stakeholders.
What We Offer

As a Biotech Systems Specialist at AmplifyBio, you can expect a competitive salary package, including a base salary of $120,000 per year, plus benefits, and opportunities for professional growth and development.

We offer a dynamic and inclusive work environment, with a commitment to diversity, equity, and inclusion. If you are passionate about working in a fast-paced, cutting-edge industry and have a strong desire to make a difference, we encourage you to apply for this exciting opportunity.



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