Quality Assurance Engineer II – Process and Validation (359)

Essential Duties and Responsibilities

• Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
• Lead or participate in Quality Risk Management and analysis.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters is provided to the site.
• Support and ensure compliance of product process transfers, including validation, from and / or to other manufacturing sites.
• Lead activities related to product introduction to the site.
• Support aseptic process simulations.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, Annual Product Quality Review (APQR), and management notification.
• Provide quality review and support for laboratory method validation / verification and laboratory information management system (LIMS).
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Travel (up to 5%) may be required.

Basic Qualifications and Capabilities :

• Bachelors degree in a scientific discipline with a minimum of 6 years Quality / cGMP experience in the pharmaceutical industry.
• Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations and Quality Risk Management.
• Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
• Strong project management, organization, and execution skills to manage multiple projects and priorities.
• Participation and leading activities to support regulatory agency inspections required.
• Project management, organization, and execution skills are required.
• Ability to apply technical expertise to solve problems and issues.
• Participating in and leading activities that support regulatory agency inspections is required.
• Excellent interpersonal and written communication skills and experience using various software / electronic applications required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.

Preferred Qualifications :

Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.