Quality Assurance Engineer - CSV (358)

About Civica: Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results. Who suffers most? Patients. Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the 1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs. More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications. Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens. Learn more about Civica’s plans and progress at www.civicarx.org Job Description The Quality Assurance Engineer will join the Civica, Inc. (“Civica”) Quality organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’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 Civica 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 Civica 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. 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 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. Physical Demands and Work Environment: This role will be expected to be on site for 80% of the work week, with exception of one day remote per week. In addition, the role will be required to be on site to perform Essential Duties and Responsibilities when physical activities are being performed on site.