QA Shop Floor Tech; 2nd Shift; w​/differential

Overview

About Civica
The global mission is to address critical shortages of essential generic injectable drugs. Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Civica has grown to include more than 60 health systems, representing over 1,400 hospitals and approximately one-third of all U.S. hospital beds. Civica has supplied medicines to federal agencies and currently serves health system members in 49 states.

Civica’s mission has expanded to CivicaScript, which aims to make quality outpatient generic medicines affordable and available. Civica’s new manufacturing facility in Virginia will produce sterile injectables and affordable biosimilar insulins. The Civica Foundation supports philanthropic efforts to bring affordable medications to all Americans. Civica is leading a movement for patients, not profits. Learn more at www.civicarx.org

Job Description

The Quality Shop Floor Tech will join the Civica, Inc. ("Civica") Quality organization at the Petersburg, Virginia site. The position supports patients and quality and compliance in the fill finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

• Perform quality review of materials and components received.
• Perform inspection on finished goods.
• Ensure adherence to Civica standard operating procedures (SOPs) and batch records on the manufacturing floor.
• Ensure real-time review of manufacturing records and cleaning records.
• Provide immediate support in the identification and documentation of nonconformances, deviations, or discrepancies on the manufacturing floor.
• Provide support as required to all manufacturing and processing areas within the facility.
• Collaborate across functions to maintain the site’s quality systems related to operations to enable reliable supply of quality generic medications to patients.
• Support manual visual inspection of filled products.
• Promote a quality mindset and quality excellence in all activities.
• Promote a safety mindset and focus on safety for all operations activities.
• Maintain SOPs and training to stay up to date with cGMPs for QA shop-floor support.
• Ensure that good documentation practices are followed and that ALCOA+ principles are followed in accordance with regulatory guidelines and Civica’s SOPs.
• Maintain current knowledge of FDA and Civica requirements to keep pace with evolving manufacturing requirements.
• Proactively identify and collaborate to resolve problems.

• High school diploma.
• Strong organization and execution skills.
• Excellent interpersonal and written communication skills and experience using software/electronic applications.
• Self-motivated, flexible, and able to work in a small, fast-paced environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Committed to delivering high quality results and collaborating with others to overcome challenges.
• Continuously looking for opportunities to learn, build skills and share knowledge with others.

• Experience in the pharmaceutical industry.
• Quality Assurance experience.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus.

The noise level in the work environment is usually low to moderate. Additionally, use of a pallet-jack or motorized walking stack may be required with appropriate training.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.