Who are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.About PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.‘Take your Career to a new Level’PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.Overview:Associate Quality Specialist supports project for strengthening data integrity compliance for electronic logs and day to day QA activities in the facility. The Quality Specialist participates as a core member of the Quality Systems CoE Team.Act as a QA representative within a cross-functional project team to support the design, introduction, and continuous improvement of electronic logbooks (eLogs) across Operations, Quality Control, and Warehouse/Logistics. Ensure alignment with ALCOA+ Data Integrity principles and global QMS requirements.RequirementsKey Responsibilities:Act as a functional QA expert within cross-functional teams to support project introduction and Right First Time performanceProvide QA oversight and input into the design and implementation of eLogs, ensuring alignment with Data Integrity expectations and global QMS standards.Apply strong quality systems knowledge to ensure robust design, including identification of risks, root cause considerations, and appropriate controls.Partner with stakeholders across Operations, QC, and Warehouse/Logistics to ensure solutions are practical, compliant, and fit for purpose.Support process mapping and risk assessments to ensure appropriate system selection and data capture approaches.Drive continuous improvement initiatives, identifying recurring issues and implementing sustainable system/process improvements.Support or lead elements of change control, CAPA development, and deviation considerations related to the project implementation.Communicate effectively across stakeholders, escalating risks and supporting decision-making where required.Contribute to maintaining inspection readiness, ensuring solutions meet regulatory expectations and withstand audit scrutiny.Experience & Skills:2–3 years’ experience in a GMP-regulated environment (QA / QC / Operations / Supply Chain / Quality Systems or similar).Experience supporting project introduction or system implementation in a regulated setting.Strong working knowledge of Data Integrity and practical application of ALCOA+ principles.Demonstrated understanding of Quality Systems, including deviations, CAPA, and change control processes.Proven ability to work effectively in cross-functional teams and influence stakeholders.Strong communication, problem-solving, and decision-making skills.Desirable:Experience with electronic logbooks or digital systems in manufacturing, laboratory, or warehousing environments.Knowledge of quality IT systems (e.g., SAP, Veeva, Kneat or similar).Experience supporting or participating in internal audits or inspection readiness activities.Exposure to lean / continuous improvement methodologies.
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