Quality Assurance Shop Floor Tech (365)

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 Quality Shop Floor Associate will join the Civica, Inc. (“Civica”) Quality organization 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. Responsibilities of the position include quality shop floor support, manufacturing documentation review, and the generation of procedures, chain of custody documents, or other records necessary to support the design, implementation, and maintenance of manufacturing processes that meets or exceeds FDA requirements. Essential Duties and Responsibilities: Perform quality review of materials and components received. Perform inspection on finished goods. Ensure adherence to Civica standard operating procedures (SOPs) and batch records while on the manufacturing floor. Ensure that real-time review of manufacturing records and cleaning records. Provide immediate support in the identification and documentation of nonconformances, deviations, or discrepancies on the manufacturing floor. Provide support as required to all manufacturing and processing areas within the facility. Working across functions, maintain the site’s quality systems related to operations to enable reliable supply of quality generic medications to patients. Support manual visual inspection of filled products. Promote a quality mindset and quality excellence approach to all activities. Promote a safety mindset and focus on safety for all operations activities. Maintain SOPs and training to stay up to date with cGMPs for QA shop-floor support. Ensure that good documentation practices are followed and that the principles of ALCOA are followed in accordance with regulatory guidelines and Civica’s SOPs. Maintain current knowledge of FDA and Civica requirements to keep pace with evolving requirements for manufacturing. Proactively identify and work collaboratively to resolve problems. Basic Qualifications and Capabilities: High school diploma. Strong organization and execution skills. Excellent interpersonal and written communication skills and experience using various software/electronic applications required. Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment. Ability to work autonomously and within established guidelines, procedures, and practices. Committed to delivering high quality results, working with others to overcome challenges, and focusing on what matters. Continuously looking for opportunities to learn, build skills and share knowledge with others. Preferred Qualifications: Experienced in the pharmaceutical industry. Quality Assurance experience.