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Quality Systems Specialist II – Investigations (348)
Location:
Petersburg, VA
Description:
About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders. Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines. Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica’s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.Civica’s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.” Civica’s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.To find out more about how Civica’s innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. ( https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189 ) To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.( https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/ ) Job Description: The Quality Systems Specialist II will join the Civica, Inc. (“Civica”) organization and its newly forming team 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 include but are not limited oversight of the quality management system (QMS) investigation and Corrective Action and Preventative Action (CAPA) program. Essential Duties and Responsibilities: Leads and responsible for the Quality Management System oversight and execution of the Deviations and CAPA program. Organizes, oversees and performs investigational write-ups within the allotted time frame. Lead or participate in root cause analysis investigations as either investigator or Quality Assurance. Responsible for completion of Root Cause Analysis (RCA) and identification of corrective/preventative actions. Approves Deviation/CAPA records. Implement, track, trend, and analyze CAPA, Deviations and Management Notifications. Summarize findings and recommendations for management and team awareness and/or present at Quality Council meetings. Working across functions to ensure on time completion of Deviations and CAPA. Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions. Lead or participate in Quality Risk Management and Data Governance Processes as needed. Participate in activities to support regulatory agency inspections. Promote a quality mindset and quality excellence approach to all activities. Maintain written procedures for Deviation and CAPA program. Act as site subject matter expert for the Deviation and CAPA program and investigation/CAPA electronic management system. Develop and maintain root cause analysis tools. Lead site to deliver compliance training sessions. Travel is limited but may occasionally be required. Basic Qualifications and Capabilities: 6 years’ experience working directly with manufacturing in the pharmaceutical or medical device industries. Appropriate combinations of experience and bachelor-level or higher education. 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: Experience with Veeva. Belt certification.
Company:
Civica Rx
Posted:
April 25 on PrismHR Hiring
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More About this Listing: Quality Systems Specialist II – Investigations (348)
Quality Systems Specialist II – Investigations (348) is a Human Resource Quality Systems Specialist II Job at Civica Rx located in Petersburg VA. Find other listings like Quality Systems Specialist II – Investigations (348) by searching Oodle for Human Resource Quality Systems Specialist II Jobs.
Quality Systems Specialist II – Investigations (348) is a Human Resource Quality Systems Specialist II Job at Civica Rx located in Petersburg VA. Find other listings like Quality Systems Specialist II – Investigations (348) by searching Oodle for Human Resource Quality Systems Specialist II Jobs.