QC Specialist II Insulin (420)
Civica

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent 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 of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica's plans and progress at www.civicarx.org

Job Description:

The QC Specialist II Insulin 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 focus on the needs of the Insulin project and all activities required to support this product.
• 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.

• Bachelor's degree in a scientific discipline with at least 8+ years' experience working in the pharmaceutical industry.
• 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.
• Wet chemistry testing by USP methods, pH, conductivity, atomic absorption, and loss on drying.
• Proficient in HPLC analyses.
• Prepare and/or review technical documents such as protocols, reports, SOPs, and testing procedures.
• Analytical method transfers, method verifications, and validations.