Quality Assurance Validation Analyst I

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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:
Validation Analyst
Charlotte, North Carolina
This Is What You'll Do:

• Adheres to company validation standards, procedures, policy and guidelines of validation process.
• Performs test case execution of GxP computerized systems (hardware, software, and regulated reports) validation protocols and documents consistent with Good Automated Manufacturing Practice (GAMP) and Blood Establishment Computer System (BECS) guidelines.
• Performs test case execution of non-GxP computerized systems validation protocols and documents.
• Performs test case execution of equipment validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP), including: donor center processing, equipment, freezers, refrigerators, temperature mapping of rooms and equipment.
• Performs test case execution of non-regulated report validation protocols and documents consistent with good engineering practices and current Good Manufacturing Practices (cGMP).
• Performs the execution of process validation protocols and documents consistent with FDA and EU guidelines.
• Evaluates validation results and provides updates to QA Validation Supervisor.
• Performs the assessment of product involved in temperature excursions.

This Is Who You Are:

• A natural leader who displays strong character and integrity
• Capable of thriving with little supervision
• A person committed to excellent customer service all day, every day
• Excited to teach, learn, and advance with a growing organization
• Self-motivated and willing to assume the initiative
• Attentive to every detail

This Is What It Takes:

• Bachelor's degree in one of the allied health sciences (chemistry, biology, medical technology), computer science, or equivalent experience.
• Two or more years of experience in an analytical positon within a regulated industry is highly desired.
• Two or more years of experience working in a validation position is highly desired.
• Knowledge of validation principles and compliance standards is strongly preferred.
• Excellent verbal and written communication skills.
• Ability to multitask between competing projects/deliverables.
• Ability to work independently assuming leading roles.

Do 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 training
• Outstanding plans for 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
• Personal 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.
Interested? Learn more online and apply now at:
octapharmahiring.com
And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along.
INNER SATISFACTION.
OUTSTANDING IMPACT.