Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace. Approximately 200 medically necessary drugs are on the U.S. Food and Drug Administration's shortage list. Manufacturing challenges and predatory pricing are both the cause and result.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Led by an experienced team of health care and pharmaceutical industry leaders.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines.
Civica is improving patient outcomes and reducing healthcare costs by making strides to ensure patients and their needs come first and that essential generic medications are accessible and affordable. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”
Civica is launching a subsidiary to enter the Outpatient pharmacy market partnering with Blue Cross Blue Shield with the goal of reducing drug prices, especially high-cost generic drugs where market forces are not working to control drug costs.
To find out more about how Civica's innovative model is directly impacting patient care, click below to read a recent article from the New England Journal of Medicine.
The Quality Control Laboratory Analyst 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 and biosimilar insulin sterile injectable medications. Responsibilities of the position include performing analytical testing on biological drug substances and sterile injectable products. Responsibilities also include maintenance of analytical equipment and executing method verification, validations, and transfers.
The role is essential to assure 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
Perform analytical testing, interpret results, 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 PDA or CAD detection 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
Minimum Qualifications (Knowledge, Skills, and Abilities)
Bachelor's degree in a scientific discipline with a minimum of 8 years' experience working in a regulated laboratory environment
Proficiency with LIMS software, analytical data acquisition software, 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