Quality Engineer II

📋 Description

• Provides quality guidance in the development and revision of computer system and equipment
• Ensures all activities related to applicable computer systems and equipment qualifications are in
• Performs the quality review of SOPs, policies, and the computer validation and equipment
• Responsible for QA oversight of the computer system validation and equipment management programs as
• Responsible for system administration of Quality Management Systems (e.g. ZenQMS, Blue Mountain)
• Responsible for electronic Archives oversight

🎯 Requirements

• Bachelor’s degree in engineering, information technology, computer science, or related discipline
• Not less than five (5) years’ experience in pharmaceutical/GxP/regulated environment
• Direct hands-on experience with computer systems validation and/or equipment qualifications
• Direct hands-on experience with GxP regulations (FDA, EPA, EU, ICH, USP, ASTM and ISO)
• Ability to provide QA oversight for the implementation, maintenance, and enhancement of a LIMS
• Ability to apply validation engineering principles to the design and implementation of projects

🎁 Benefits

• Medical Insurance (HDHP with HSA; PPO)
• Dental Insurance
• Vision Insurance
• Flexible Spending Account (medical; dependent care)
• Short Term Disability | Long Term Disability Life Insurance
• Paid Time Off (4 weeks per year)