Sample Management Associate

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

Position Summary  

The Sample Management Associate 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.

The role is essential to assure the Petersburg site’s manufacturing and operations activities comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices, Good Distribution Practices) and expectations for the development and reliable supply of quality medicines.

Responsibilities of the position include supporting the establishment of sample management procedures and cGMP sample management activities for the Quality Control department.  Responsibilities also include but are not limited to sample collection, retention, and sample oversight of the outsourced testing program.

Essential Duties and Responsibilities 

• Work across functions to support the development and maintenance of the sample management program.
• Ensure samples of incoming material are taken according to internal procedures.
• Ensure samples are stored according to the proper storage conditions and are stored securely per procedure and relevant FDA and controlled drugs are handled in accordance with Drug Enforcement Administration (DEA) regulatory requirements.
• Communicate, coordinate and ship samples to the appropriate external testing facilities for release and stability.
• Coordinate collection and storage and oversight of reserve samples.
• Receive and process results from external testing facility.
• Maintain a current list of samples with anticipated due dates for sample turnaround tracking.  Communicate sample status effectively to supervisor.
• Maintain a separate storage location for sample lots under investigation.
• Conduct destruction of samples upon batch release from the Quality Control lab.
• Inventory and inspect raw material and finished product retention samples.
• Complete chemical inventory and ordering supplies as required.
• Conduct other duties as required to 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), and management notification.
• Participate in quality risk analysis.
• Proactively identify and work collaboratively to resolve problems taking risk-based and compliant approaches to solutions.
• Practice and promote a safety and quality mindset and quality excellence approach to all activities
• Travel limited but may occasionally be required.

Preferred Qualifications:

Experience in Drug Enforcement Agency requirements for the handling and distribution of controlled substances is desired.

Physical Demand and Work Environment:

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. Specific vision abilities required by this position include color vision, close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

The employee must have the ability to lift approximately 50 lbs, stand for 2 to 3 hours at a time, and walk long distances. Vision screening may be required.

The employee must have the capability to don gowning/PPE for entry into the aseptic core and supporting areas for extended periods of time. This will include standing, bending, reaching, kneeling, etc.