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Job DescriptionJob Description
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 DescriptionPharma-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 our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.Company DescriptionPharma-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 our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.
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 DescriptionPharma-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 our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.Company DescriptionPharma-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 our inception, our services have resulted in a project experience level and personnel resource base ranking among the highest worldwide.