Validation Analyst 1

About the Role

Adheres to company validation standards, procedures, policy and guidelines of validation process.

Responsibilities

• 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.

Qualifications

• 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 position 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.

Benefits

• 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