Quality Systems Specialist II
1 day ago
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 Systems Specialist II 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 include but are not limited to responsibilities associated with the quality management system (QMS) investigation and Corrective Action and Preventative Action (CAPA) program
Essential Duties and Responsibilities:
- Participates and supports 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.
- Leads training related to the investigation and CAPA system and root cause analysis tools.
- 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.
- Travel is limited but may occasionally be required.
Basic Qualifications and Capabilities:
- 8 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.
- Continuously looking for opportunities to learn, build skills, and share knowledge with others.
- Interact with other functions and be able to take ownership of and follow through on assigned projects.
Preferred Qualifications:
- Experience with Veeva.
- Yellow belt certification.
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