Quality Engineer

Job DescriptionJob Descriptionn

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:

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  Lead and manage CAPA investigations related to raw materials and manufacturing processes

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  Conduct thorough root cause analyses and implement effective corrective actions

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  Investigate non-conformances and material-related deviations

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  Collaborate with cross-functional teams including Manufacturing, R&D, and Supplier Quality

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  Support raw material qualification and ongoing quality monitoring

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  Maintain documentation in compliance with GMP, ISO 13485 , and internal SOPs

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  Participate in internal audits and support external regulatory inspections

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  Monitor and trend quality data to identify systemic issues and drive improvements

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  Ensure timely closure of CAPAs and documentation in quality systems

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Ideal Candidate Profile:

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  Bachelor’s degree in Engineering, Chemistry, or related field

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  3+ years of experience in Quality Engineering within a regulated industry 

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  Strong understanding of CAPA processes , root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA)

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  Experience with raw material investigations and supplier interactions

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  Familiarity with ISO 13485 , FDA QSR, and GMP standards

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  Excellent communication and documentation skills

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  Proficiency in Microsoft Office and quality management systems (TrackWise or similar)

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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.