Octapharma Plasma
Validation Analyst II
Octapharma Plasma, Charlotte, North Carolina, United States, 28245
How to Maximizeyour opportunity to do rewarding work,your future leadership potential,and your career growth?
Join an Industry Leader[Become one, too!]
Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:
SR. VALIDATION MANAGER
Charlotte, North Carolina (on site 5 days a week)
This Is 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.Ensure regulatory requirements are met during development of equipment validation protocols.Demonstrates an understanding of and the 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 to include, but not limited to:
Plasma case and unit thawChanges in collection volumesChanges in plasma bottle sizeChanges in plasma collection process
Analyzes and interprets validation and study data to determine if requirements are met. 12. Reviews and approves executed equipment validation testing protocols. 13. Develops equipment validation summaries to support executed protocol and address deviations found during execution.Performs deviation investigations identified during the equipment validation process and ensures timely resolution of all nonconformities.Supports entire fleet of donor centers through meeting established SLA requirements when responding to requests.Supports laboratory and plasma storage warehouse through meeting established SLA requirements when responding to requests.Manages support ticket documentation and statuses through to closure.Ensures 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.Ensures equipment performance meets quality and regulatory requirements through assessment of major repairs performed on equipment across donor center fleet, laboratory, and plasma storage freezer.This Is What It Takes:
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 needDo Satisfying Work. Earn Real Rewards and Benefits.
We're widely known and respected for our benefits and for leadership that is supportive and hands-on.
Formal trainingOutstanding plans for medical, dental, and vision insuranceHealth savings account (HSA)Employee assistance program (EAP)Wellness program401 (k) retirement planPaid time offCompany-paid holidaysPersonal time
More 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 at an impressive pace, and so is the positive impact of our work. 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.
INNER SATISFACTION.
OUTSTANDING IMPACT.
Join an Industry Leader[Become one, too!]
Octapharma Plasma offers professional opportunities that make a meaningful difference. We enhance the lives of patients who need our life-saving medicines. We reward the donors who provide the plasma we collect to make them. And we inspire growth and development in the teams at our donation centers, offices, and labs. We invite you to do the same in this role:
SR. VALIDATION MANAGER
Charlotte, North Carolina (on site 5 days a week)
This Is 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.Ensure regulatory requirements are met during development of equipment validation protocols.Demonstrates an understanding of and the 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 to include, but not limited to:
Plasma case and unit thawChanges in collection volumesChanges in plasma bottle sizeChanges in plasma collection process
Analyzes and interprets validation and study data to determine if requirements are met. 12. Reviews and approves executed equipment validation testing protocols. 13. Develops equipment validation summaries to support executed protocol and address deviations found during execution.Performs deviation investigations identified during the equipment validation process and ensures timely resolution of all nonconformities.Supports entire fleet of donor centers through meeting established SLA requirements when responding to requests.Supports laboratory and plasma storage warehouse through meeting established SLA requirements when responding to requests.Manages support ticket documentation and statuses through to closure.Ensures 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.Ensures equipment performance meets quality and regulatory requirements through assessment of major repairs performed on equipment across donor center fleet, laboratory, and plasma storage freezer.This Is What It Takes:
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 needDo Satisfying Work. Earn Real Rewards and Benefits.
We're widely known and respected for our benefits and for leadership that is supportive and hands-on.
Formal trainingOutstanding plans for medical, dental, and vision insuranceHealth savings account (HSA)Employee assistance program (EAP)Wellness program401 (k) retirement planPaid time offCompany-paid holidaysPersonal time
More 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 at an impressive pace, and so is the positive impact of our work. 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.
INNER SATISFACTION.
OUTSTANDING IMPACT.