Manufacturing Associate

Infotree Global Solutions; Greenville (NC); On-site; USD 65,000 - 85,000; Full time

Job summary

Infotree Global Solutions is seeking a Manufacturing Quality Assurance professional to oversee sterile and aseptic manufacturing operations, including filling, packaging, inspection, and documentation. You will ensure compliance with cGMP, SOPs, and site quality standards while collaborating with manufacturing, QA, and engineering teams.

The role requires 4+ years in QA/QC or a regulated environment, strong documentation, and the ability to operate on the manufacturing floor under gowning and

Qualifications

• 4+ years of experience in QA, QC, manufacturing, operations, or a regulated environment.
• Experience working under GMP/cGMP or other regulated quality systems.
• Strong documentation, analytical, troubleshooting, and communication skills.
• Ability to work on the manufacturing floor and follow gowning/cleanroom requirements.
• Knowledge of aseptic techniques.

Responsibilities

• Perform routine QA assessments of manufacturing areas, personnel, equipment, and documentation.
• Provide QA guidance to manufacturing personnel regarding cGMP, SOPs, documentation practices, and aseptic techniques.
• Review batch records, procedures, forms, and training documentation for compliance and accuracy.
• Support deviation investigations, change controls, root cause analysis, and CAPA activities.
• Identify and elevate quality issues and assist with appropriate corrective actions.
• Participate in quality investigations and provide QA support during manufacturing events.
• Monitor sterile/aseptic operations including filling, packaging, inspection, and manufacturing activities.
• Partner with production leadership to troubleshoot process, equipment, and quality issues.
• Identify opportunities for continuous improvement and process optimization.
• Maintain accurate and compliant quality documentation.
• Support a strong quality culture through employee coaching and cross-functional collaboration.

Education

Bachelor's degree in a relevant field

Job description

The Manufacturing Associate will provide quality oversight and support for pharmaceutical/biopharmaceutical manufacturing operations, with a primary focus on sterile and aseptic manufacturing, filling, packaging, inspection, and documentation. This position will work closely with Manufacturing, Quality Control, Engineering, and other cross-functional teams to ensure compliance with cGMP, SOPs, and site quality requirements.

Key Responsibilities

• Perform routine QA assessments of manufacturing areas, personnel, equipment, and documentation.
• Provide QA guidance to manufacturing personnel regarding cGMP, SOPs, documentation practices, and aseptic techniques.
• Review batch records, procedures, forms, and training documentation for compliance and accuracy.
• Support deviation investigations, change controls, root cause analysis, and CAPA activities.
• Identify and elevate quality issues and assist with appropriate corrective actions.
• Participate in quality investigations and provide QA support during manufacturing events.
• Monitor sterile/aseptic operations including filling, packaging, inspection, and manufacturing activities.
• Partner with production leadership to troubleshoot process, equipment, and quality issues.
• Identify opportunities for continuous improvement and process optimization.
• Maintain accurate and compliant quality documentation.
• Support a strong quality culture through employee coaching and cross-functional collaboration.

Basic Qualifications

• Bachelor's degree in a relevant scientific, engineering, or technical field preferred.
• 4+ years of experience in QA, QC, manufacturing, operations, or a regulated environment.
• Experience working under GMP/cGMP or other regulated quality systems.
• Strong documentation, analytical, troubleshooting, and communication skills.
• Ability to work on the manufacturing floor and follow gowning/cleanroom requirements.
• Ability to work a 12-hour 2-2-3 rotating schedule.

Preferred Experience

• Pharmaceutical or biopharmaceutical manufacturing.