Stability Analyst (227)
Civica

Job Info

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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

Position Summary

The Stability 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 sterile injectable medications.

The role is essential to assure the Petersburg site's Stability Program complies with applicable regulatory requirements and International Council for Harmonization (ICH) guidelines.

Responsibilities of the position include working cross-functionally to establish and maintain the stability program at Civica Petersburg. Responsibilities also include but are not limited to the generation, review and/or approval of policies, procedures, reports, protocols, investigation, change controls and other records necessary for the stability program.

Essential Duties and Responsibilities

• Work across functions to support the development and maintenance of the stability program at Civica Petersburg.
• Author stability protocols for new drug products and annual commitment batches, as per current procedures and regulatory requirement.
• Build plans for ensuring stability commitments are met.
• Support the shipment of samples to the appropriate external testing facilities.
• Acts as primary contact with Contract laboratories to coordinate and monitor stability protocols and testing schedules.
• Responsible for assessing stability requirements related to changes.
• Participate or lead stability investigations.
• Track sample receipt, testing and obtain results and raw data from contract labs.
• Build and manage stability data in the LIMS system.
• Supports Annual Product Quality Reviews and Annual Reports by providing relevant stability reports as needed.
• Support overall sample management and Quality Control Operations as needed.
• Compile and evaluate stability metrics, trend data and report to Management.
• Ensure that all aspects of the handling, stability samples at the site comply with Civica and relevant FDA and Drug Enforcement Administration (DEA) regulatory requirements.
• Practice and promote a safety and quality mindset and a quality excellence approach to all activities.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor's degree in a scientific discipline with a minimum of 8 years Quality/CGMP experience in the pharmaceutical industry.
• Experience in managing stability studies.
• Excellent written/oral communication skills with a strong discipline in Microsoft Programs is 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.
• Committed to delivering high quality results, overcoming challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills and share learning.

Preferred Qualifications:

• Experience with Laboratory Information Management Systems (LIMS).

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