QA Ops Shop Floor Specialist (412)

Location: Petersburg, Virginia, United States; onsite at a sterile injectable manufacturing facility

Company

hirify.global is a nonprofit pharmaceutical company focused on producing reliable, affordable generic medications and reducing drug shortages.

What you will do

• Provide quality assurance oversight of manufacturing operations, including cleanroom behavior, aseptic techniques, and gowning procedures.
• Identify procedural departures, assess discrepancies, initiate deviations, and resolve complex quality issues.
• Develop, review, and approve temporary, non-routine, and procedural documentation.
• Lead area walkthroughs, cross-functional meetings, remediation planning, and quality improvement programs.
• Provide training and guidance to shop-floor personnel and represent Quality Assurance in site-wide assessments.
• Prioritize team activities, share quality knowledge, and proactively identify operational risks.

Requirements

• Bachelor’s degree or higher in a scientific discipline.
• At least 4 years of experience in pharmaceutical, biotech, cell therapy, or medical device cGMP-regulated manufacturing.
• Experience with sterile pharmaceutical isolator technology, combination products, or medical devices.
• Experience training personnel on cGMP regulations, SOPs, and quality systems.
• Experience managing change controls, deviations, investigations, and CAPA records in quality management systems.
• Strong data interpretation, documentation, communication, decision-making, and leadership skills, with proficiency in MS Office and other digital tools.

Culture & Benefits

• Work in a cross-functional quality culture supporting reliable supplies of essential medications.
• Fast-paced manufacturing environment with changing priorities and opportunities to lead peers.
• Physical work includes standing, walking, reaching, handling objects, and occasionally lifting or moving up to 25 pounds.
• Reasonable accommodations are available for individuals with disabilities.
• Equal opportunity, drug-free workplace compliant with applicable ADA regulations.