Energy Jobline ZR is hiring: Quality Engineer in Atlanta in Atlanta
Energy Jobline ZR, Atlanta, GA, United States, 30383
Quality Engineer
PharmaBio Serv is seeking a Quality Engineer to support quality systems and compliance activities related to Corrective and Preventive Actions (CAPA) and raw material investigations. This role is critical in ensuring product integrity, regulatory compliance, and continuous improvement across manufacturing and supply chain operations.
Key Responsibilities:
- Lead and manage CAPA investigations related to raw materials and manufacturing processes
- Conduct thorough root cause analyses and implement effective corrective actions
- Investigate non-conformances and material-related deviations
- Collaborate with cross-functional teams including Manufacturing, R&D, and Supplier Quality
- Support raw material qualification and ongoing quality monitoring
- Maintain documentation in compliance with GMP, ISO 13485, and internal SOPs
- Participate in internal audits and support external regulatory inspections
- Monitor and trend quality data to identify systemic issues and drive improvements
- Ensure timely closure of CAPAs and documentation in quality systems
Ideal Candidate Profile:
- Bachelor’s degree in Engineering, Chemistry, or related field
- 3+ years of experience in Quality Engineering within a regulated industry
- Strong understanding of CAPA processes, root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA)
- Experience with raw material investigations and supplier interactions
- Familiarity with ISO 13485, FDA QSR, and GMP standards
- Excellent communication and documentation skills
- Proficiency in Microsoft Office and quality management systems (TrackWise or similar)
Company Description
Pharma-Bio Serv, a global consulting firm headquartered in Puerto Rico, has been dedicated exclusively to providing services to the largest biotechnology & bio‑engineering companies within the regulated industry for more than 29 years. Since its inception, the company has achieved a project experience level and personnel resource base ranking among the highest worldwide.