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Manufacturing Quality Inspector
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Manufacturing Specialist II – Syringe Line
4 months ago
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. )
To learn more about Civica's plans to bring affordable insulin to Americans living with diabetes, click here to read an article in BioSpace.
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Job Description
The Manufacturing Specialist II will play a key part in the facility start up with primary responsibilities focused around supporting daily manufacturing operations on the nested line and the timely production of pharmaceuticals at the Civica Petersburg, VA site. This key position will support manufacturing production execution, running equipment, change management, investigations, training, and development. The ideal candidate will have a consistent track record of achieving results in a face-paced manufacturing environment.
Essential Duties and Responsibilities:
Collaborate with Manufacturing, Quality Operations, Environmental Health and Safety and other cross-functional teams to meet production needs.Support onboarding and provide technical training of Manufacturing Operators on process equipment including Fillers with integrated Isolators, ATEC commodities processing, Parts Washer, Autoclaves, Single Use Technology, and Aseptic Process Simulations.Initiate and complete manufacturing investigations including root cause analysis and product impact assessment.Drive the creation, revision, and management of manufacturing documents such as Batch Records and SOPs.Lead efficient GMP document and record reviews to minimize routing time.Provide technical expertise and support to production teams, addressing issues and challenges as they arise.Supports regulatory inspections as an SME for the area.Ability to quickly adapt and adjust priorities in response to changes in the production schedule due to unforeseen disruptions with the intent to minimizing impact to operations.Onsite presence, as the role requires time on the manufacturing floor and cross-functional collaboration.Develop and track KPI metrics to identify opportunities, failure points, and trending modelsBasic Qualifications and Capabilities:Associate degree with 6+ years demonstrated ability in a cGMP production environment.High School degree with 8+ years of experience of cGMP production experience may be considered.Experience with sterile fill finish manufacturing.Detailed-oriented with a focus on accuracy in creating and updating production documents.Knowledge of GMP, regulatory requirements, and industry best practices.Proficiency in Microsoft Office suite.Strong communication and collaboration skills, with a commitment to meeting high-quality standards.Must be able to complete eye exam and have the visual ability to detect defects.Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.Basic math skills to perform required calculations (multiplication/division),Good deviation and investigation writing skills.Ability to work autonomously and within established guidelines, procedures, and practices.Preferred Qualifications:Knowledge of high-speed aseptic filling and barrier system technology (isolator, RABS).Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.Equipment qualification experience.Experience in using ERP systems.Position ID: 339Shift: Flex schedule to work 1st or 2nd shift hours. Monday through Friday.
