Quality Engineer II - Combination Products (930)

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

Responsibilities of the position include working across functions to provide hands-on Quality oversight and Quality Engineering input to develop maintain drug delivery device / combination products for small and large molecules.

Responsibilities of the position include supporting quality management systems and oversight to ensure the product process validation, equipment qualification, and Quality Risk Management meet cGMP and Civica compliance requirements leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

The position is an onsite role at Civica Petersburg, Virginia facility.

Essential Duties and Responsibilities :

• Working across functions, to ensure and provide Quality oversight of the establishment and maintenance of Civica’s quality systems related to pre-filled injectable syringe and pen combination products.
• Work with cross functional teams to provide Quality oversight for validation and qualification activities and ensure work for developed drug delivery device / combination products for small and large molecules is performed in a compliant and controlled manner.
• Support evaluation and validation of packaging solutions.
• Partner with the medical device development team to ensure all elements of the design history file are executed and maintained.
• Ensure Product Development and Design Transfer Plans are in accordance with CFR 820 quality system regulations and ISO 13845 medical device standards.
• Support process development and technology transfer of combination products.
• Provide quality support for all operational compliance aspects of sterile fill finish manufacturing of combination products including but not limited to batch record review and batch release.
• Ensure Standard Operating Procedures, and training is in place to maintain compliance with cGMP.
• Maintain current knowledge of local and international combination product and medical device 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 quality processes and systems across the product lifecycle including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), complaints and management notification.
• 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.
• Support product process transfers, including validation, from and / or to other manufacturing sites.
• Support activities related to combination product(s) introduction to the site.
• Generation, review and / or approval of policies, procedures, reports, and other records.
• Participate in Quality Risk Management and analysis.
• Participate and support other commissioning, qualification, and validation activities as needed.
• Support product process transfers, including validation, from and / or to other manufacturing sites.
• Support activities related to product introduction to the site.
• Provide quality review and support for laboratory method validation / verification and laboratory information management system (LIMS).
• Provide support to equipment, facilities and utilities qualification as needed.
• Work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Travel (up to 5%) may be required.

Basic Qualifications and Capabilities :

Preferred Qualifications :

Physical Demands and Work Environment :

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and / or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.