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BioSpace

QA Shop Floor Tech, (903) 2nd Shift (w/10% differential pay)

BioSpace, Virginia State University, Virginia, us, 23806

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QA Shop Floor Tech, (903) 2nd Shift (w/10% differential pay)

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QA Shop Floor Tech, (903) 2nd Shift (w/10% differential pay)

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BioSpace . 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, are members. Civica supplies medicines to various U.S. government agencies and operates a new manufacturing facility in Virginia producing essential sterile injectables and biosimilars. The Civica Foundation supports efforts to make affordable medications, including insulin, accessible to all Americans. Learn more at

www.civicarx.org . Job Description

The Quality Shop Floor Tech II supports Civica’s quality operations at the Petersburg, VA site, focusing on manufacturing documentation review, quality support, and compliance with FDA standards. Responsibilities

Perform quality review of materials and finished goods. Ensure adherence to SOPs and batch records. Support real-time review and documentation of manufacturing activities. Identify and document nonconformances and deviations. Maintain quality systems and support manual visual inspections. Promote a culture of quality and safety. Ensure compliance with cGMPs and regulatory guidelines. Proactively resolve issues and collaborate across functions. Qualifications

High school diploma. Strong organizational and communication skills. Experience with software applications. Self-motivated and adaptable to a fast-paced environment. Ability to work independently and follow procedures. Desire to learn and share knowledge. Preferred

Pharmaceutical industry experience. Quality assurance background. Physical & Work Environment

Requires speaking, hearing, manual dexterity, standing, walking, sitting, and occasional lifting up to 25 pounds. The environment is generally low to moderate noise. Accommodations available for disabilities. Equal Opportunity Employer, drug-free workplace, ADA compliant. Additional Details

Seniority level: Entry level Employment type: Full-time Job function: Quality Assurance

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