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 QC Lab Analyst 2nd Shift will join the Civica, Inc. 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, insulin, and biosimilar sterile injectable medications. Responsibilities of the position include performing analytical testing on sterile injectable products. Responsibilities also include maintenance of analytical equipment and executing method verification, validations, and transfers.

The role is essential to ensure the intended materials are utilized for manufacturing and meet the required standards to ensure the finished product meets the applicable standards of identity, strength, quality, and purity. You will help Civica achieve its mission of delivering quality medicines that are available and affordable to everyone by complying with applicable regulatory standards (e.g., Current Good Manufacturing Practices and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines.

Essential Duties and Responsibilities:

• This position will be working on the second shift. Training will occur on the first shift until the transition to the second shift.
• Perform analytical testing and interpret and document actions and results using proper documentation practices.
• Participate in analytical method transfers and perform method verifications/validations.
• Notify management of OOS, OOT or atypical results on the day of discovery with the appropriate level of urgency.
• Lead and/or participate in laboratory investigations.
• Ability to complete HPLC analysis with minimal supervision. Experience with Empower software, and diode array and single quad detection experience is a plus.
• Maintain LIMS data.
• Contribute to and promote a safety culture by adhering to established safety procedures, engineering controls and appropriate PPE.
• Maintain a clean and organized work environment in accordance with 6S lean principles.
• Inform management of continuous improvement and opportunities
• Lead and/or participate in 6S and OPEX initiatives
• Ability to work independently or in a team setting effectively.
• Complete chemical inventory and order supplies as required.
• Conduct other duties as required by management.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with a minimum of 4+ years’ experience working in a regulated laboratory environment.
• Proficiency with LIMS software, analytical data acquisition software, and Microsoft Office® applications, including Excel, Word, and PowerPoint.
• Ability to multi-task and change priorities in a fast-paced environment.
• Self-motivated and willingness to learn and help others.
• Working knowledge of relevant FDA and ICH guidelines and USP requirements preferred.
• Experience with the following:
• Wet chemistry testing by USP methods, pH, conductivity, atomic absorption, and loss on drying.
• Proficient in HPLC analysis.
• Prepare and/or review technical documents such as protocols, reports, SOPs and testing procedures.
• Analytical method transfers, method verifications, and validations.