Civica Rx
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QC Specialist II Insulin (420)
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Civica Rx . Get AI-powered advice on this job and more exclusive features. About Civica Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals across the U.S., have joined Civica. The organization supplies medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile, currently serving in 49 states. Civica’s mission includes making quality outpatient generic medicines affordable and accessible through CivicaScript, developing quality generics with trusted partners, and passing significant cost savings to consumers. The new 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables, including affordable biosimilar insulins, to ensure access regardless of insurance status. The Civica Foundation supports philanthropic efforts to manufacture and distribute affordable medications, focusing initially on insulin for all Americans, partnering with leaders across the diabetes ecosystem. Civica is committed to leading a movement for patients, not profits, aiming to eliminate shortages and stabilize prices for the benefit of patients. Learn more at
www.civicarx.org . Job Description The QC Specialist II Insulin will join Civica’s organization at the Petersburg, Virginia site, supporting the manufacture and supply of essential generic, insulin, and biosimilar sterile injectables. Responsibilities include performing analytical testing, maintaining equipment, and executing method verifications, validations, and transfers. The role ensures materials meet standards for identity, strength, quality, and purity, complying with regulatory standards like cGMP and FDA guidance, to deliver quality medicines affordably. Essential Duties And Responsibilities Focus on the needs of the Insulin project, supporting all related activities. Perform analytical testing, document results, and interpret data. Participate in method transfers, verifications, and validations. Report OOS, OOT, or atypical results immediately. Lead or participate in laboratory investigations. Complete HPLC analysis with minimal supervision; experience with Empower software and diode array detection is a plus. Maintain LIMS data. Promote safety culture by following procedures and PPE use. Maintain a clean, organized workspace following lean principles. Suggest and implement continuous improvement initiatives. Work independently or as part of a team effectively. Manage chemical inventory and supplies. Perform other duties as assigned. Basic Qualifications And Capabilities Bachelor’s degree in a scientific discipline with 8+ years in the pharmaceutical industry. Proficiency with LIMS, analytical data software, and Microsoft Office. Ability to multitask in a fast-paced environment. Self-motivated with a willingness to learn and assist others. Knowledge of FDA, ICH guidelines, and USP requirements. Experience with USP methods, pH, conductivity, atomic absorption, and loss on drying. Proficient in HPLC analyses. Ability to prepare and review technical documents. Experience with method transfers, verifications, and validations. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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QC Specialist II Insulin (420)
role at
Civica Rx . Get AI-powered advice on this job and more exclusive features. About Civica Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports. Shortages put patients at risk and waste hospital resources. Civica is a market-based nonprofit created in 2018 by health systems and philanthropies to prevent and mitigate drug shortages. Nearly 60 health systems, representing over 1,400 hospitals across the U.S., have joined Civica. The organization supplies medicines to the U.S. Department of Veterans Affairs, Department of Defense, and the Strategic National Stockpile, currently serving in 49 states. Civica’s mission includes making quality outpatient generic medicines affordable and accessible through CivicaScript, developing quality generics with trusted partners, and passing significant cost savings to consumers. The new 140,000 sq ft manufacturing facility in Virginia will produce sterile injectables, including affordable biosimilar insulins, to ensure access regardless of insurance status. The Civica Foundation supports philanthropic efforts to manufacture and distribute affordable medications, focusing initially on insulin for all Americans, partnering with leaders across the diabetes ecosystem. Civica is committed to leading a movement for patients, not profits, aiming to eliminate shortages and stabilize prices for the benefit of patients. Learn more at
www.civicarx.org . Job Description The QC Specialist II Insulin will join Civica’s organization at the Petersburg, Virginia site, supporting the manufacture and supply of essential generic, insulin, and biosimilar sterile injectables. Responsibilities include performing analytical testing, maintaining equipment, and executing method verifications, validations, and transfers. The role ensures materials meet standards for identity, strength, quality, and purity, complying with regulatory standards like cGMP and FDA guidance, to deliver quality medicines affordably. Essential Duties And Responsibilities Focus on the needs of the Insulin project, supporting all related activities. Perform analytical testing, document results, and interpret data. Participate in method transfers, verifications, and validations. Report OOS, OOT, or atypical results immediately. Lead or participate in laboratory investigations. Complete HPLC analysis with minimal supervision; experience with Empower software and diode array detection is a plus. Maintain LIMS data. Promote safety culture by following procedures and PPE use. Maintain a clean, organized workspace following lean principles. Suggest and implement continuous improvement initiatives. Work independently or as part of a team effectively. Manage chemical inventory and supplies. Perform other duties as assigned. Basic Qualifications And Capabilities Bachelor’s degree in a scientific discipline with 8+ years in the pharmaceutical industry. Proficiency with LIMS, analytical data software, and Microsoft Office. Ability to multitask in a fast-paced environment. Self-motivated with a willingness to learn and assist others. Knowledge of FDA, ICH guidelines, and USP requirements. Experience with USP methods, pH, conductivity, atomic absorption, and loss on drying. Proficient in HPLC analyses. Ability to prepare and review technical documents. Experience with method transfers, verifications, and validations. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries
Pharmaceutical Manufacturing
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