Validation Analyst 1

Job Summary

Want to Expand
your career-development potential,
your ability to help donors and patients,
and your access to professional opportunities?

We’re growing fast.
[You can, too!]

There are so many ways Octapharma Plasma can enhance your life and your career. Our strong growth is creating great learning and career development opportunities throughout our company, and especially our donation centers. Because you’re someone who loves to learn, enjoys people, and has a real heart to help, we encourage you to join us as a:Validation Analyst 1

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 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.

Physical Requirements

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. Managers who truly want you to grow and excel.

• Formal training
• Outstanding plans for medical, dental, and vision insurance
• Health savings account (HSA)
• Flexible spending account (FSA)
• Tuition Reimbursement
• Employee assistance program (EAP)
• Wellness program
• 401k retirement plan
• Paid time off
• Company paid holidays
• Personal time

Pay Transparency

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:

octapharmaplasma.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.