Octapharma Plasma, Inc.
Validation Analyst II
Octapharma Plasma, Inc., Charlotte, North Carolina, United States, 28245
Overview
Join to apply for the
Validation Analyst II
role at
Octapharma Plasma, Inc. We’re growing fast and offer learning and career development opportunities throughout our company, especially at our donation centers. If you enjoy learning, working with people, and helping others, consider joining us as a
Validation Analyst II . What you’ll do
Develops and maintains equipment validation policy and adheres to regulatory requirements. Performs the development and execution of process validation protocols and documents consistent with FDA and EU guidelines. Ensures regulatory requirements are met during development of equipment validation protocols. Demonstrates understanding of and use of all OPI systems. Develops equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP). Develops and maintains donor center freezer, refrigerator, and Anti-D refrigerator validation protocols to be executed fleetwide. Develops and maintains donor center supply room temperature mapping protocols to be executed fleetwide. Develops and maintains laboratory freezer and refrigerator validation protocols. Develops and maintains plasma storage warehouse freezer and processing area validation protocols. Develops protocols for temperature studies (e.g., plasma case and unit thaw, changes in plasma bottle size, changes in plasma collection process). Analyzes and interprets validation and study data to determine if requirements are met; reviews and approves executed validation testing protocols; develops equipment validation summaries to address deviations. Performs deviation investigations and ensures timely resolution of nonconformities. Supports donor centers and laboratories in meeting SLA requirements; manages support ticket documentation and closure. Ensures quality of plasma units prior to shipping and notifies customers if shipped product may have quality impact. Ensures equipment performance meets quality and regulatory requirements through assessment of major repairs across donor centers, laboratories, and storage facilities. Qualifications
Bachelor’s degree in IT, life science, or related field required. Three years’ experience in biologics, drug manufacturing, or a FDA-regulated laboratory required. Minimum of two (2) years of validation experience in a regulated industry required. Minimum of two (2) years of software validation experience required. Knowledge of cGMP, FDA regulations, SOPs, validation principles and compliance standards. GAMP training completed. Excellent interpersonal, written, and verbal communication skills. Ability to work independently and with all levels of an organization. Normal travel up to 15% (travel requirements may vary by business need). Physical Requirements
Ability to sit for extended periods and use a computer and office equipment. Ability to lift up to 20 pounds occasionally and to reach, bend, and stoop as needed. Ability to travel up to 20% by airplane or vehicle. Ability to communicate effectively in writing and verbally; assistive devices if needed. Benefits and culture
Formal training and comprehensive medical, dental, and vision plans. 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.
With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing and value teamwork, compassion, and expertise in making a meaningful difference. Interested? Learn more online and apply now at:
octapharmaplasma.com
#J-18808-Ljbffr
Join to apply for the
Validation Analyst II
role at
Octapharma Plasma, Inc. We’re growing fast and offer learning and career development opportunities throughout our company, especially at our donation centers. If you enjoy learning, working with people, and helping others, consider joining us as a
Validation Analyst II . What you’ll do
Develops and maintains equipment validation policy and adheres to regulatory requirements. Performs the development and execution of process validation protocols and documents consistent with FDA and EU guidelines. Ensures regulatory requirements are met during development of equipment validation protocols. Demonstrates understanding of and use of all OPI systems. Develops equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP). Develops and maintains donor center freezer, refrigerator, and Anti-D refrigerator validation protocols to be executed fleetwide. Develops and maintains donor center supply room temperature mapping protocols to be executed fleetwide. Develops and maintains laboratory freezer and refrigerator validation protocols. Develops and maintains plasma storage warehouse freezer and processing area validation protocols. Develops protocols for temperature studies (e.g., plasma case and unit thaw, changes in plasma bottle size, changes in plasma collection process). Analyzes and interprets validation and study data to determine if requirements are met; reviews and approves executed validation testing protocols; develops equipment validation summaries to address deviations. Performs deviation investigations and ensures timely resolution of nonconformities. Supports donor centers and laboratories in meeting SLA requirements; manages support ticket documentation and closure. Ensures quality of plasma units prior to shipping and notifies customers if shipped product may have quality impact. Ensures equipment performance meets quality and regulatory requirements through assessment of major repairs across donor centers, laboratories, and storage facilities. Qualifications
Bachelor’s degree in IT, life science, or related field required. Three years’ experience in biologics, drug manufacturing, or a FDA-regulated laboratory required. Minimum of two (2) years of validation experience in a regulated industry required. Minimum of two (2) years of software validation experience required. Knowledge of cGMP, FDA regulations, SOPs, validation principles and compliance standards. GAMP training completed. Excellent interpersonal, written, and verbal communication skills. Ability to work independently and with all levels of an organization. Normal travel up to 15% (travel requirements may vary by business need). Physical Requirements
Ability to sit for extended periods and use a computer and office equipment. Ability to lift up to 20 pounds occasionally and to reach, bend, and stoop as needed. Ability to travel up to 20% by airplane or vehicle. Ability to communicate effectively in writing and verbally; assistive devices if needed. Benefits and culture
Formal training and comprehensive medical, dental, and vision plans. 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.
With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing and value teamwork, compassion, and expertise in making a meaningful difference. Interested? Learn more online and apply now at:
octapharmaplasma.com
#J-18808-Ljbffr