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:A fantastic opportunity has arisen for a QC Associate Microbiology Specialist.You will provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role holds more senior responsibilities within the Microbiology Laboratory including (but not limited to) documentation development, report writing, execution of method and equipment validation, drug product result authorization, providing microbiological support for site, performance of bench experiments as required.You will be capable of self-management and decision making and will demonstrate a high level of leadership, initiative, collaboration, and coaching to facilitate the team in becoming a high-performance organization. Central to this objective will be the active engagement and communication with all internal (e.g. QC Analytical, Tech Ops, IPT, QA) and external (e.g. Microbiology COE). A high level of innovation, enthusiasm and drive will be required to deliver technical excellence is required for this role.This is a maternity cover contract for 11 months, start date as soon as possible. No shifts required, the person will need to be onsite in the beginning of contract, but with time there might be possibility for a hybrid model.Application Deadline for this role is 6th FebRole Functions:Development and execution of Microbiology test methods and project validations.Troubleshooting of issues which arise during the execution of validation studies and routine tests.Development of training modules.Microbiology Support to Site InvestigationsDriving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.Authoring and managing change controls, procedures, test methods and deviations.Result authorization for microbiological samples to support batch release.LIMS System updatesAssessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.Supporting lab stock management and financial control as required.Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.Makes decisions within guidelines and policies which impact microbiology projects.Ensures highest safety standards.May be required to perform other duties as assigned.Experience, Knowledge & Skills:Strong Planning and Organising skillsIn-depth knowledge of the veterinary marketIn depth knowledge of pharmacovigilance legislation and guidelinesWide-ranging and sound communication skillsAbility to work well within in a high performance team structureAbility to work under pressure to deadlinesSound interpersonal skills for dealing with a wide range of people in a variety of situationsAbility to communicate (verbally and in writing) clearly and succinctlySelf-starter with drive and focusSound commercial acumen with high levels of integrity and trustworthinessGood presentation skillsSound IT and software skillsPassion and persistenceQualifications & Education:In order to excel in this role, you will more than likely have:Bachelor's Degree or higher preferred; ideally in Microbiology or a closely related discipline.Demonstrated change management skills (CEM) with continuous improvement.Strong knowledge in execution, validation and development of microbiology related test methods i.e. Bioburden, Endotoxin and Sterility testing.At least 5 years' experience in the Microbiology Pharmaceutical industry or a similar operating environment.