Associate QC Analyst Incoming
1 month ago
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 Associate QC Analyst Incoming 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 sterile injectable medications.
The role is essential to ensure 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.
The position's responsibilities include, but are not limited to, overseeing the incoming sampling process, supporting quality control (QC) operations, performing QC testing, and conducting and documenting incoming inspection and sampling activities of components and raw materials.
Essential Duties and Responsibilities:
- Work across functions to support the development and maintenance of incoming sample management.
- Conduct and document material, component, and packaging sampling according to the established sampling plans.
- Support the development of sampling plans across the product lifecycle.
- Conduct sampling according to established procedures.
- Support and participate in testing and Acceptable Quality Level (AQL) checks and document the results using proper documentation practices.
- Ensure that all aspects of the handling, and manufacturing of pharmaceutical products at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
- Support the shipment of samples to the appropriate external testing facilities as needed.
- Complete laboratory inventory and order supplies as required.
- Participate and/or lead various Quality Systems processes, including change controls, investigations, and corrective and preventative action (CAPA) plans.
- 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.
Basic Qualifications and Capabilities:
- Bachelor's degree in a scientific discipline with a minimum of 2+ years of Quality/CGMP experience in the pharmaceutical industry.
- Excellent written/oral communication skills and strong discipline in Microsoft Programs are required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.
- Ability to work autonomously within established guidelines, procedures, and practices.
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