Job Description

About Civica

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. Civica is led by an experienced team of healthcare and pharmaceutical industry leaders.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and one-third of all U.S. hospital beds. Civica has also begun to supply the U.S. Department of Veteran\xe2\x80\x99s Affairs, the U.S. Department of Defense and the U.S. Strategic National Stockpile of essential medicines.

Civica recently announced plans to expand its mission, via a unit called CivicaScript, to into the outpatient pharmacy space and to manufacture and distribute insulins that, once approved, will be available to people with diabetes at significantly lower prices than insulins currently on the market. The availability of Civica\xe2\x80\x99s affordable insulins, beginning in 2024, will benefit people with diabetes who have been forced to choose between life sustaining medicines and living expenses, particularly those uninsured or underinsured who often pay the most out of pocket for their medications.

Civica\xe2\x80\x99s mission is to ensure that quality generic medications are accessible and affordable to everyone. Since established, the #1 Policy for the Civica team has been \xe2\x80\x9cDo What Is in the Best Interest of Patients.\xe2\x80\x9d Civica\xe2\x80\x99s manufacturing facility in Petersburg, Virginia, is the future home of affordable insulin and essential sterile injectable medicines. The facility is currently in late-stage construction and hiring for the site is well-underway.

To find out more about how Civica\xe2\x80\x99s innovative model is directly impacting patient care, click to read a summary from the New England Journal of Medicine. ( )

To learn more about Civica\xe2\x80\x99s plans to bring affordable insulin to Americans living with diabetes, click to read an article in BioSpace.

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Position Summary

The Associate Quality Control Laboratory Analyst will join the Civica, Inc. (\xe2\x80\x9cCivica\xe2\x80\x9d) 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\xe2\x80\x99s 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 testing on biological drug substances and sterile injectable products. Responsibilities also include maintenance of equipment.

The role is essential to assure the intended materials utilized for manufacturing are tested 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 routine testing, analyze information, interpret results, and document actions and results using proper documentation practices.
• Participate in analytical method transfers and method verifications/validations.
• Participate in laboratory investigations.
• Participate in equipment maintenance.
• Maintain a clean and organized work environment in accordance with 6S lean principles.
• Use existing procedures and instructions to solve routine problems.
• Apply technical and functional knowledge to deliver high quality work.
• Ability to work independently when instruction is received or in a team setting.
• Achieves goals assigned by manager.
• Inform management of continuous improvement and opportunities.
• Complete chemical inventory and ordering supplies as required.
• Contribute to and promote a safety culture by adhering to established safety procedures, engineering controls and appropriate PPE.
• Conduct other duties as required by management.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor\xe2\x80\x99s degree in a scientific discipline with a minimum of 2 years\xe2\x80\x99 experience working in a regulated laboratory environment.
• Proficiency with Microsoft Office\xc2\xae applications including Excel, Word, and PowerPoint.
• Ability to multi-task and change priorities in a fast-paced environment.
• Self-motivated, uses time effectively and efficiently and willingness to learn and help others.
• Follows and meets schedules and timelines.
• Working knowledge of relevant FDA and ICH guidelines and USP requirements preferred.

Experience with the following:

• Understands theory of basic analytical laboratory techniques such as High-Performance Liquid Chromatography (HPLC).
• Hands on experience with wet chemistry techniques and testing such as pH, Moisture, and conductivity analysis.
• Experience with analytical analysis.
• Prepare technical documents such as protocols, reports, procedures and testing procedures.

Preferred Qualifications:

• Experience with Empower software.
• HPLC analytical experience.

PI32671029-8722-d44448022d5d

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