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Job Description
The Quality Assurance Engineer will join the company’s Quality organization at the Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Virginia site serves as the company’s new fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.
Responsibilities of the position include maintaining quality systems and oversight to ensure the validation/qualification and operation of computerized systems meet cGMP and company compliance requirements at the onset of building the facility leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.
Responsibilities also include, but are not limited to, the generation, review and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of company’s Engineering functions including computerized system validation and ongoing operation activities of facility, utilities, process, equipment, instrumentation and to ensure FDA data integrity requirements are met.
Essential Duties and 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 computerized system validation activities to ensure work is performed in a compliant and controlled manner and leverage experience and share industry best practices to support continuous improvement of site CSV program.
- 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 with a focus on data integrity.
- 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.
- Participate or lead in quality risk analysis.
- Proactively identify and work collaboratively to resolve problems 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.
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Basic Qualifications and Capabilities:
- A bachelor’s degree in a scientific discipline or computerized systems with a minimum of 4+ years relevant experience.
- Experience providing computer system validation oversight.
- Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
- Experience in developing and managing scientific studies, identifying critical aspects of the topic being studied, and defining appropriate acceptance criteria to the study.
- Strong project management, organization, and execution skills to manage multiple projects and priorities.
- Participation and leading activities to support regulatory agency inspections required.
- Leverage experience and share industry best practices to support continuous improvement of site procedures.
- 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. Continuously looking for opportunities to learn, build
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Preferred Qualifications:
- Experience in facility, utilities and equipment qualification.
- Experience across the product development and commercialization lifecycle including change management and associated implementation strategies.
- Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.