Johnson & Johnson Innovative Medicine
QA Auditor, 3rd shift (2 openings)
Johnson & Johnson Innovative Medicine, Gurabo, Gurabo, us, 00778
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Overview We are searching for the best talent for QA Auditor, 3rd shift (2 openings available) to be located in Gurabo, Puerto Rico. The QA Auditor is accountable for ensuring compliance with all material specifications, current Good Manufacturing Practices, and effective written procedures.
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 Education:
This position requires a bachelor degree in science with a major in Microbiology, Biology, Chemistry or related science.
Experience and Skills:
A minimum of 2 years of work experience in a Pharmaceutical industry.
Knowledge on Training System, Documentation System, Investigation and Change Control System, eLIMS.
Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.
Other:
Requires working the third shift, extended hours, holidays and/or weekends.
The position requires employee to be proficient in Spanish and English and must have excellent ability to technical writing in English and Spanish.
This position may require up to 10% of domestic and/or international travel.
Seniority Level Not Applicable
Employment Type Full‑time
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
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 other characteristics 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 & Johnson 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
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Overview We are searching for the best talent for QA Auditor, 3rd shift (2 openings available) to be located in Gurabo, Puerto Rico. The QA Auditor is accountable for ensuring compliance with all material specifications, current Good Manufacturing Practices, and effective written procedures.
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 Education:
This position requires a bachelor degree in science with a major in Microbiology, Biology, Chemistry or related science.
Experience and Skills:
A minimum of 2 years of work experience in a Pharmaceutical industry.
Knowledge on Training System, Documentation System, Investigation and Change Control System, eLIMS.
Must exercise judgment on the resolution of final release problems to meet company standards for quality, cost and critical success factors.
Other:
Requires working the third shift, extended hours, holidays and/or weekends.
The position requires employee to be proficient in Spanish and English and must have excellent ability to technical writing in English and Spanish.
This position may require up to 10% of domestic and/or international travel.
Seniority Level Not Applicable
Employment Type Full‑time
Job Function Quality Assurance
Industries Pharmaceutical Manufacturing
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 other characteristics 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 & Johnson 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, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
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