What are the responsibilities and job description for the Manufacturing Associate position at Infotree Global Solutions?
Job Summary:
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 escalate 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.
- Sterile or aseptic processing.
- Fill-finish operations.
- Batch record review.
- Deviation and investigation management.
- Change control and CAPA.
- Root Cause Analysis.
- Technical writing.
- Six Sigma or CQA certification.
Salary : $25 - $27