Quality Assurance Engineer II – Process and Validation (359)

About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative. 

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at  www.civicarx.org

Job Description

The Quality Assurance Engineer 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 of the position include supporting quality systems and oversight to ensure the product process validation, cleaning validation, Quality Risk Management and quality laboratory 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 to ensure FDA requirements are met.  

Essential Duties and Responsibilities:

• Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
• Lead or participate in Quality Risk Management and analysis.
• 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.
• Support and ensure compliance of product process transfers, including validation, from and/or to other manufacturing sites.
• Lead activities related to product introduction to the site.
• Support aseptic process simulations.
• Support quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, laboratory control, Annual Product Quality Review (APQR), and management notification.
• Provide quality review and support for laboratory method validation/verification and laboratory information management system (LIMS).
• Proactively identify and work collaboratively to resolve problems by 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 5%) may be required.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with a minimum of 6 years Quality/cGMP experience in the pharmaceutical industry. 
• Experience in process and cleaning validation, LIMS systems, Aseptic Process Simulations and Quality Risk Management.
• Knowledge in 21CFR Part 11, Electronic Records and Signatures and data integrity is required.
• Strong project management, organization, and execution skills to manage multiple projects and priorities.
• Participation and leading activities to support regulatory agency inspections required.
• 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:

Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices.