Quality Assurance Engineer
The Quality Assurance Engineer’s responsibilities include maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, equipment, and computer systems meet cGMP and company compliance requirements from the onset of facility start up to a successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Essential Duties and Responsibilities:
- Work with validation and engineering teams to provide quality oversight for validation and qualification activities. 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, and Annual Product Quality Review (APQR).
- Provide quality review and support for calibration and maintenance programs and ensure they are running in accordance with GMP regulation and site procedures.
- Lead or participate in deviation investigations.
- Lead or participate in quality risk analysis.
- Proactively identify and work collaboratively to resolve problems applying functional and technical expertise while 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 10%) may be required.
Basic Qualifications and Capabilities:
- 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 21 CFR Part 11, Electronic Records and Signatures and data integrity is required.
- Experience across the product development and commercialization lifecycle.
- Technical expertise in sterile pharmaceutical isolator technology, and combination product.