QC Specialist II Insulin (420) jobs in United States
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Civica Rx · 4 months ago

QC Specialist II Insulin (420)

Civica Rx is a nonprofit organization dedicated to addressing critical shortages of essential generic injectable drugs in U.S. healthcare. The QC Specialist II Insulin will perform analytical testing on sterile injectable products, maintain analytical equipment, and ensure compliance with regulatory standards to support the manufacture and supply of quality medications.

Pharmaceutical
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H1B Sponsor Likelynote

Responsibilities

This position will focus on the needs of the Insulin project and all activities required to support this product
Perform analytical testing and interpret 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 diode array and single quad detection experience 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 order supplies as required
Conduct other duties as required by management

Qualification

HPLC analysisLIMS softwareFDA guidelinesAnalytical method validationWet chemistry testingEmpower softwareContinuous improvementTeamworkSelf-motivated

Required

Bachelor's degree in a scientific discipline with at least 8+ years' experience working in the pharmaceutical industry
Proficiency with LIMS software, analytical data acquisition software, and 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
Wet chemistry testing by USP methods, pH, conductivity, atomic absorption, and loss on drying
Proficient in HPLC analyses
Prepare and/or review technical documents such as protocols, reports, SOPs, and testing procedures
Analytical method transfers, method verifications, and validations

Preferred

Experience with Empower software, and diode array and single quad detection experience is a plus

Company

Civica Rx

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Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.

H1B Sponsorship

Civica Rx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (2)
2022 (1)
2021 (2)

Funding

Current Stage
Growth Stage
Total Funding
$3M
2025-08-07Grant· $3M

Leadership Team

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Ned McCoy
CEO
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Dave Sehgal
Chief Manufacturing and Supply Chain Officer
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Company data provided by crunchbase