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 BiotechWe provide cloud‑based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.Employee Value PropositionEmployees are the “heartbeat” of PSC Biotech. We provide unparalleled empowering career development through learning & development, in‑house training, mentorship, and constant guidance to facilitate career progression. We believe in creating high‑performing teams that can exceed our client’s expectations by delivering quality, staying under budget, and meeting timelines.OverviewAn exciting opportunity has arisen for a QC Analyst to join the QC In Process Control team, based in a newly 5S‑certified analytical laboratory. This role offers excellent exposure across both Drug Substance and Drug Product manufacturing in a fast‑paced, highly compliant GMP environment.The QC In Process team delivers comprehensive in‑process analytical and microbiological testing, supporting manufacturing operations across the site and testing of incoming raw materials and packaging materials to support downstream pack line activities.Due to the critical, around‑the‑clock nature of in‑process testing, this role is part of a 4‑cycle shift team, supporting continuous manufacturing operations.QC In Process is a high‑performing, team‑based group where colleagues are flexible, multi‑skilled, and empowered to make decisions. The team operates to an exceptionally high standard of quality, compliance, and safety with a strong focus on continuous improvement, standard work, and 5S.This role requires a high level of initiative, energy, and motivation, together with strong organisational skills and the ability to thrive in a dynamic manufacturing environment.RequirementsRole ResponsibilitiesReport to the QC Team Lead and support internal customers by delivering high‑quality, compliant test results in accordance with GMP standards.Perform primary review of QC raw data and trend results.Prepare protocols, summaries, and reports, including documents submitted directly to pharmaceutical regulatory agencies.Draft and update QC Standard Operating Procedures (SOPs).Act as a technical subject matter expert (SME) and provide training and support to other analysts in areas of expertise.Evaluate analytical and microbiological results against defined acceptance criteria.Conduct and document laboratory investigations through to completion.Maintain the laboratory in a constant state of audit and inspection readiness.Interact directly with regulatory agency inspectors during audits and inspections.Interface with other functions including Manufacturing, Quality Assurance, Facilities, and external contractors as required.Other Duties As AssignedExcellent written and verbal communication skills.Strong customer focus, with personal accountability for speed, quality, and accuracy of delivery.Self‑motivated, with the ability to work under pressure in a fast‑paced environment.Team‑oriented, with active participation in team development and continuous improvement, including standard work and 5S.Demonstrated success in achieving goals as part of a high‑performing team in a growing organisation.Proven adaptability and flexibility to support an evolving operational environment.Education and ExperienceBSc in a scientific or engineering discipline with 5+ years of relevant cGMP laboratory experience, or MSc with 3+ years of relevant cGMP laboratory experience.Shift pattern: 24/7 shift (2 weeks days and rotating to 2 week nights).12‑month contract with a possibility of an extension.
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