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Johnson & Johnson, QA Auditor, 3rd shift (2 openings) - Application via WayUp
WayUp, Gurabo, Gurabo, us, 00778
Johnson & Johnson, QA Auditor, 3rd shift (2 openings)
Location: Gurabo, Puerto Rico, United States of America
This role is with Johnson & Johnson. Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured. Learn more at https://www.jnj.com
Key Responsibilities
Review batch records thoroughly, perform continuous flow and quarantine assessments, and coordinate product disposition for WIPs, intermediates, finished goods, and raw materials (API and excipients) to ensure compliance with specifications and cGMP standards.
Collaborate with cross-functional teams—Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance, and QC Labs—to proactively identify, address, and resolve compliance issues.
Make informed, data-driven recommendations and decisions to prevent process deviations, product non-conformances, and quality issues, bringing up critical concerns promptly.
Document quality assessments, deviations, investigations, and corrective actions meticulously, ensuring full regulatory and internal compliance.
Support continuous improvement by identifying process gaps, inefficiencies, and risks, and proposing effective corrective and preventive actions.
Keep current with industry regulations, standards, and internal policies to uphold the highest quality standards.
Qualifications
Bachelor’s degree in Science with a major in Microbiology, Biology, Chemistry, or related science.
Minimum of 2 years of work experience in a pharmaceutical industry.
Knowledge of Training System, Documentation System, Investigation and Change Control System, and eLIMS.
Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost, and critical success factors.
Requires working the third shift, extended hours, holidays, and/or weekends.
Proficiency in Spanish and English; excellent technical writing ability in both languages.
May require up to 10% domestic and/or international travel.
Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or any other characteristic protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Jonn is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us for further assistance.
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This role is with Johnson & Johnson. Johnson & Johnson is committed to building a world where complex diseases are prevented, treated, and cured. Learn more at https://www.jnj.com
Key Responsibilities
Review batch records thoroughly, perform continuous flow and quarantine assessments, and coordinate product disposition for WIPs, intermediates, finished goods, and raw materials (API and excipients) to ensure compliance with specifications and cGMP standards.
Collaborate with cross-functional teams—Operations, Logistics, Warehouse, Technical Operations, Site Services, Quality Assurance, and QC Labs—to proactively identify, address, and resolve compliance issues.
Make informed, data-driven recommendations and decisions to prevent process deviations, product non-conformances, and quality issues, bringing up critical concerns promptly.
Document quality assessments, deviations, investigations, and corrective actions meticulously, ensuring full regulatory and internal compliance.
Support continuous improvement by identifying process gaps, inefficiencies, and risks, and proposing effective corrective and preventive actions.
Keep current with industry regulations, standards, and internal policies to uphold the highest quality standards.
Qualifications
Bachelor’s degree in Science with a major in Microbiology, Biology, Chemistry, or related science.
Minimum of 2 years of work experience in a pharmaceutical industry.
Knowledge of Training System, Documentation System, Investigation and Change Control System, and eLIMS.
Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost, and critical success factors.
Requires working the third shift, extended hours, holidays, and/or weekends.
Proficiency in Spanish and English; excellent technical writing ability in both languages.
May require up to 10% domestic and/or international travel.
Equal Opportunity Employer Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or any other characteristic protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Jonn is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us for further assistance.
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