Pharma Bioserv
Atlanta, Ga, Fulton County, Ga, United States
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)
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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)
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