QA Ops Shop Floor Associate (386)

About the role

The Quality Assurance Operations Shop Floor Associate is part of the Quality Assurance Operations team at Civica’s Petersburg, Virginia manufacturing facility. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. This role ensures ongoing compliance with cGMP requirements on the manufacturing floor.

Responsibilities

• Provide Quality Assurance oversight on the manufacturing floor during all operations regarding procedures, reports, batch records, aseptic technique, gowning, nonconformances, product sampling, and/or other records to support manufacturing processes.
• Conduct on-the-floor review of batch records during execution to ensure compliance with approved procedures; communicate and resolve discrepancies with manufacturing operators and/or supervisors.
• Utilize electronic management systems such as Veeva, Deacom, and Blue Mountain RAM.
• Facilitate Quality oversight through walkthroughs, Gemba, and process observations to ensure adherence to cGMP practices.
• Identify and implement improvements to procedures and processes as part of continuous improvement initiatives.
• Work across functions to ensure operational compliance in all aspects of product manufacturing.
• Enforce adherence to all Civica standard operating procedures (SOPs) on the manufacturing floor.
• Promote a quality mindset and excellence in all activities, as well as a safety-focused approach to operations.
• Ensure accurate on-the-floor review of manufacturing records, batch quantities, and accountability calculations.
• Provide immediate support in identifying and documenting nonconformances, deviations, or discrepancies on the manufacturing floor.
• Support all manufacturing and processing areas within the facility as required by job assignment and schedule.

Requirements

• Bachelor's degree or above in a scientific discipline.
• Minimum of 2+ years of experience within a pharmaceutical, biotech, cell therapy, or medical device cGMP-regulated manufacturing environment.
• Experience in sterile pharmaceutical isolator technology, combination products, or medical devices.
• Demonstrated experience delivering training on cGMP regulations, SOPs, and quality systems.
• Excellent written and verbal communication skills, with the ability to present technical data effectively to varied audiences.
• Ability to work in a fast-paced team environment and lead peers through changing priorities.
• Detail-oriented and task-focused, with the ability to meet deadlines and support work prioritization.

Physical Demands and Work Environment

The physical demands described are representative of those required to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

• Regularly required to speak or hear.
• Frequently required to use hands or fingers, handle or feel objects, tools, or controls.
• Occasionally required to stand, walk, sit, and reach with hands and arms.
• Must occasionally lift and/or move up to 25 pounds.
• Requires close vision, distance vision, and the ability to adjust focus.
• Work environment noise level is usually low to moderate.