Quality Control Lab Analyst

Petersburg, VA

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’s 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’s 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’s 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 “Do What Is in the Best Interest of Patients.” Civica’s 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’s innovative model is directly impacting patient care, click here to read a summary from the New England Journal of Medicine. (https://catalyst.nejm.org/doi/full/10.1056/CAT.21.0189)

To learn more about Civica’s plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.

(https://www.biospace.com/article/civica-is-rallying-leaders-to-make-insulin-affordable-by-2024-/)

Position Summary

The Quality Control Laboratory 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 and biosimilar insulin sterile injectable medications.  Responsibilities of the position include performing analytical testing on biological drug substances and sterile injectable products.  Responsibilities also include maintenance of analytical equipment and executing method verification, validations, and transfers. 

The role is essential to assure 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

  • Perform analytical testing, interpret results, 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 PDA or CAD detection 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 ordering supplies as required.
  • Conduct other duties as required by management.

Minimum Qualifications (Knowledge, Skills, and Abilities)

  • Bachelor’s degree in a scientific discipline with a minimum of 8 years’ experience working in a regulated laboratory environment.
  • Proficiency with LIMS software, analytical data acquisition software, 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 preferred.

Experience with the following:

  • Wet chemistry testing by USP methods, pH, conductivity, atomic absorption and loss on drying.
  • Proficient in HPLC analysis.
  • Prepare and/or review technical documents such as protocols, reports, SOPs and testing procedures.
  • Analytical method transfers and validations.

 Preferred Qualifications:

  • Experience with biological methods.