QA Engineer

Essential Responsibilities

• Provides quality guidance in the development and revision of computer system and equipment procedures and policies (e.g. validations, change control, security)
• Ensures all activities related to applicable computer systems and equipment qualifications are in compliance with national/international GxPs, 21 CFR Part 11, Annex 11, Annex 15, and GAMPs
• Performs the quality review of SOPs, policies, and the computer validation and equipment qualification master plan, as required
• Responsible for QA oversight of the computer system validation and equipment management programs as well as working with other departments/consultants/vendors to plan, implement, and complete all validation/qualification projects (e.g. LIMS, ELN, QCBD, equipment software, etc.)
• Responsible for system administration of Quality Management Systems (e.g. ZenQMS, Blue Mountain)
• Responsible for electronic Archives oversight
• Responsible for the maintenance of the Computer System Validation Status listing and Equipment Master Listing
• Reviews and approves equipment out of tolerances investigations
• Performs vendor qualification of vendors, contractors, consultants, and technicians that will participate in computer validation/equipment qualification activities
• Confirms periodic reviews of validated computer systems and equipment are performed, including reviewing periodic reviews and confirm all required follow-up actions are completed
• Responsible for QA review and approval of validation documentation for new and existing computer systems/equipment subject to validation
• Reviews and approves for QA, deviations incident reports for executed validation and qualification documents. Ensures assignable causes are identified and addresses corrective actions, as needed
• Serves as QA representative for the testing of the Business Continuity (e.g. IT testing) and computer system validations and equipment qualification during regulatory agency and sponsor inspections
• Responsible for QA review and approval of change controls and Out of Tolerances to ensure timely closure
• Perform duties with minimal QA Engineer Management oversite
• Other duties as needed

Minimum Acceptable Qualifications

Education/Experience:

• 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)

Skills:

• Project management skills not required, but preferred
• Knowledge of and technical competency in GAMP guidelines and evaluating systems lifecycle principles
• Ability to apply validation engineering principles to the design and implementation of projects
• Knowledge of IT infrastructure and information database systems
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company procedures/policies
• Ability to work in fast-paced environment where multiple projects are in process and must be completed in a timely manner
• Advanced computer skills in Microsoft Office (Word, Excel, Outlook, etc.)
• Excellent written and verbal communication skills
• Versatility, flexibility, and willingness to work within constantly changing priorities
• Ability to deal effectively with a diversity of individuals at all organizational levels