Quality Assurance Engineer

Position Summary

We are looking for a Quality Assurance Engineer who will be responsible in maintaining the company’s quality systems, equipment, facility, and processes to ensure they are run in accordance with GMP regulation and site procedures.

Duties & Responsibilities

- Working across functions, to ensuring the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems and processes.

- 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.

- 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.

- Works across functions to develop and implement processes.

- Ensure compliance of product and process transfers, including validation, from and/or to other manufacturing sites.

- Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.

- Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification.

- Provide quality review and support for calibration and maintenance programs and ensure they are run in accordance with GMP regulation and site procedures.

Required Qualifications        

Bachelor’s degree in a scientific discipline with a minimum of 7 years Quality/cGMP experience in the pharmaceutical industry. Experience in facility and equipment qualification, process validation, computer system validation, and calibration and maintenance programs. 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. 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. Serve as a Quality subject matter expert to support driving investigations to root cause. Leverage experience and share industry best practices to support continuous improvement of site procedures. 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. Excellent interpersonal and written communication skills and experience using various software/electronic applications required.  

Preferred Qualifications

Experience across the product development and commercialization lifecycle. Technical expertise in sterile pharmaceutical isolator technology, and combination product.