Manufacturing Associate - Quality

Infotree Global Solutions; Greenville (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Infotree Global Solutions in Greenville, NC is seeking a Manufacturing Associate to provide QA oversight for sterile and aseptic manufacturing operations, including filling, packaging, inspection, and documentation. The role collaborates with Manufacturing, Quality Control, and Engineering to ensure compliance with cGMP and SOPs on the site.

Ideal candidates will have a Bachelor's in a relevant field and 4+ years in QA/QC or regulated environments, with strong documentation, analytical, and

Qualifications

• Bachelor's degree preferred in a relevant scientific/engineering field.
• 4+ years in QA, QC, manufacturing, operations, or a regulated environment.
• Experience with 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.

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.

Skills

QA experience

GMP/cGMP

Documentation

Analytical skills

Troubleshooting

Communication

Gowning/cleanroom

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.