Civica Rx
About Civica:
Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare, with over 300 medications currently reported in shortage according to industry and FDA reports.
Shortages pose risks to patients and waste hospital resources.
Civica, founded in 2018 by health systems and philanthropies, is a market-based nonprofit dedicated to preventing and mitigating drug shortages. Nearly 60 health systems, representing over 1,400 hospitals and about one-third of U.S. hospital beds, are members. Civica supplies medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile, operating in 49 states.
The organization has expanded beyond hospitals to reach consumers through CivicaScript, which aims to make affordable, quality outpatient generic medicines available. Civica partners with manufacturers, payors, PBMs, and pharmacies to pass significant cost savings to consumers.
Its new 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables currently in or near shortage, along with biosimilar insulins to ensure lower-cost options are accessible nationwide.
The Civica Foundation, a 501(c)(3), supports efforts to manufacture and distribute affordable medications, with a focus on bringing affordable insulin to all Americans, engaging stakeholders across the diabetes ecosystem.
Civica advocates for patients, emphasizing that eliminating shortages and high prices benefits public health.
Learn more at
www.civicarx.org Job Description:
The QC Specialist II Insulin will join Civica's team at the Petersburg, Virginia site, focusing on analytical testing of sterile injectable products, maintaining equipment, and executing method verifications, validations, and transfers. This role ensures materials meet quality standards to produce safe, effective medicines, complying with regulatory standards such as cGMP and FDA guidance. Essential Duties and Responsibilities:
Support the Insulin project through analytical testing and documentation. Participate in method transfers, verifications, and validations. Report OOS, OOT, or atypical results promptly. Lead or participate in laboratory investigations. Perform HPLC analysis, with experience in Empower software and diode array detection a plus. Maintain LIMS data integrity. Promote safety culture and adhere to safety procedures and PPE requirements. Maintain a clean, organized workspace following 6S principles. Identify and communicate opportunities for continuous improvement. Contribute to 6S and OPEX initiatives. Work effectively independently or as part of a team. Manage chemical inventory and supplies. Perform other duties as assigned. Basic Qualifications and Capabilities:
Bachelor’s degree in a scientific discipline with 8+ years’ experience in the pharmaceutical industry. Proficiency with LIMS, analytical data software, and MS Office. Ability to multitask in a fast-paced environment. Self-motivated with a willingness to learn and assist others. Knowledge of FDA, ICH, and USP guidelines. Experience with wet chemistry, pH, conductivity, atomic absorption, and loss on drying. Proficiency in HPLC analyses. Ability to prepare and review technical documents, protocols, reports, SOPs, testing procedures. Experience with method transfers, verifications, and validations.
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www.civicarx.org Job Description:
The QC Specialist II Insulin will join Civica's team at the Petersburg, Virginia site, focusing on analytical testing of sterile injectable products, maintaining equipment, and executing method verifications, validations, and transfers. This role ensures materials meet quality standards to produce safe, effective medicines, complying with regulatory standards such as cGMP and FDA guidance. Essential Duties and Responsibilities:
Support the Insulin project through analytical testing and documentation. Participate in method transfers, verifications, and validations. Report OOS, OOT, or atypical results promptly. Lead or participate in laboratory investigations. Perform HPLC analysis, with experience in Empower software and diode array detection a plus. Maintain LIMS data integrity. Promote safety culture and adhere to safety procedures and PPE requirements. Maintain a clean, organized workspace following 6S principles. Identify and communicate opportunities for continuous improvement. Contribute to 6S and OPEX initiatives. Work effectively independently or as part of a team. Manage chemical inventory and supplies. Perform other duties as assigned. Basic Qualifications and Capabilities:
Bachelor’s degree in a scientific discipline with 8+ years’ experience in the pharmaceutical industry. Proficiency with LIMS, analytical data software, and MS Office. Ability to multitask in a fast-paced environment. Self-motivated with a willingness to learn and assist others. Knowledge of FDA, ICH, and USP guidelines. Experience with wet chemistry, pH, conductivity, atomic absorption, and loss on drying. Proficiency in HPLC analyses. Ability to prepare and review technical documents, protocols, reports, SOPs, testing procedures. Experience with method transfers, verifications, and validations.
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