Validation Specialist

3 weeks ago

Charlotte, North Carolina, United States Octapharma Plasma Full time

Unlock Your Potential as a Validation Analyst II

At Octapharma Plasma, we're committed to enhancing the lives of patients who need our life-saving medicines. As a Validation Analyst II, you'll play a critical role in ensuring the quality and safety of our products.

Key Responsibilities:

  • Develop and maintain equipment validation policy and adhere to regulatory requirements.
  • Perform the development and execution of process validation protocols and documents consistent with FDA and EU guidelines.
  • Ensure regulatory requirements are met during development of equipment validation protocols.
  • Demonstrate an understanding of and the use of all OPI systems.
  • Develop equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP).
  • Develop and maintain donor center freezer, refrigerator, and Anti-D refrigerator validation protocols to be executed fleetwide.
  • Develop and maintain donor center supply room temperature mapping protocols to be executed fleetwide.
  • Develop and maintain laboratory freezer and refrigerator validation protocols.
  • Develop and maintain plasma storage warehouse freezer and processing area validation protocols.
  • Develop protocols for temperature studies to include, but not limited to:
    • Plasma case and unit thaw
    • Changes in collection volumes
    • Changes in plasma bottle size
    • Changes in plasma collection process
  • Analyze and interpret validation and study data to determine if requirements are met.
  • Review and approve executed equipment validation testing protocols.
  • Develop equipment validation summaries to support executed protocol and address deviations found during execution.
  • Perform deviation investigations identified during the equipment validation process and ensure timely resolution of all nonconformities.
  • Support entire fleet of donor centers through meeting established SLA requirements when responding to requests.
  • Support laboratory and plasma storage warehouse through meeting established SLA requirements when responding to requests.
  • Manage support ticket documentation and statuses through to closure.
  • Ensure quality of plasma units across donor center fleet prior to shipping through assessment of product exposed to temperatures outside of acceptable range.
  • Responsible for ensuring customer is notified when shipped product may have quality impact.
  • Ensure equipment performance meets quality and regulatory requirements through assessment of major repairs performed on equipment across donor center fleet, laboratory, and plasma storage freezer.

Requirements:

  • Bachelor's degree in IT, life science or related field required.
  • Three years' experience biologics, drug manufacturing, or medical device industry or FDA regulated laboratory required.
  • Minimum of two (2) years of validation experience in regulated industry required.
  • Minimum of two (2) years of software validation experience required.
  • Demonstrated knowledge of cGMPs, FDA regulations, SOP implementation, and validation principles and compliance standards.
  • Completion of GAMP training.
  • Demonstrated excellent interpersonal, written, and verbal communication skills.
  • Demonstrated ability to work independently.
  • Demonstrated experience working with all levels in an organization.
  • Normal amount of travel is expected and may be up to 15%. Requirements may increase depending on business need

Why Join Octapharma Plasma?

We're a company that values our employees and offers a range of benefits, including formal training, outstanding medical, dental, and vision insurance, health savings account (HSA), employee assistance program (EAP), wellness program, 401(k) retirement plan, paid time off, company-paid holidays, and personal time.

About Octapharma Plasma, Inc.

We collect plasma to create life-saving medicines for patients worldwide. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch.

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