Associate Specialist Quality Control, Carlow

About PSC Biotech

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. We provide cloud‑based software solutions for Quality Management, Regulatory Inspections, and metrology services to over 350 clients worldwide.Associate Specialist Quality Control

We are seeking an Associate Specialist Quality Control to provide technical support to the QC Microbiology Lab and operations, ensuring the continued manufacture and supply of quality pharmaceutical products. Key Responsibilities

Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures. Supporting and owning environmental monitoring risk assessments and qualification. Generating quarterly and annual trend reports. Understanding and applying regulatory/compliance and compendial requirements, staying current on upcoming regulatory changes.Developing and executing microbiology test methods and project validations. Troubleshooting issues during validation studies and routine tests. Developing training modules. Providing microbiology support to site investigations and projects related to environmental monitoring and utilities monitoring.Driving continuous improvement initiatives, including lean lab initiatives and method optimization/re‑development. Authoring and managing change controls, procedures, test methods, and deviations. Authorizing microbiological sample results to support batch release. Updating GLIMS system. Assessing compendial and quality manual updates pertaining to the microbiology lab and environmental control.Supporting lab stock management and financial control as required. Interpreting customer needs, assessing requirements, and identifying solutions to non‑standard requests. Making decisions within guidelines and policies that impact microbiology projects. Ensuring highest safety standards. Performing other duties as assigned.Qualifications

Required

Bachelor’s degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or a related life sciences field. Minimum 3 years of hands‑on experience in microbiology/QC, specifically in environmental monitoring and utilities monitoring, supporting site projects, trending, risk assessments, and data analysis.Ability to author procedures, change controls, deviations, reports, and work within regulatory/compendial requirements. Strong troubleshooting, decision‑making, and ability to drive improvements such as lean lab initiatives and method optimization. Strong microbiology background and understanding of aseptic processing, environmental monitoring programs, and contamination control in sterile manufacturing.Experience in a GMP QC laboratory with knowledge of regulatory expectations. Familiarity with ALCOA(+) data integrity principles, electronic laboratory systems, and controlled documentation. Entry‑to‑early‑career level with growing technical competence; able to perform routine tasks with limited discretion.Preferred

Experience with problem solving, decision making, and scheduling laboratory testing/tasks.

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