QC Bioassay Analyst

  About PSC Biotech Who we are? 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 Proposition Employees 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. Job Title: QC Bioassay Analyst   Role Description ·         Our Site has an immediate opportunity for a number of QC Bioassay Analyst to join our Quality Operation Laboratory. You will operate as part of the QC team performing the allocated testing and laboratory-based duties and although it is preferable that Analysts have Immunoassay and cell culture experience, we are open to considering applicants that fulfil the duties as detailed below. ·         Reporting to the Bioassay Manager / Associate Director, the team is working a 2-cycle shift pattern of 7am-3pm and 3pm-11pm (Monday-Friday) rotating weekly ·         Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.   Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. Requirements Role Functions: ·         Perform and review a range of techniques such as immunoassays, cell-based potency bioassays and aseptic techniques as part of routine and non-routine testing and project work to ensure processes and end products comply with corporate and regulatory requirements to facilitate product release. ·         Work as directed by the Bioassay Manager / Associate Director, according to Company safety policies, cGMP and cGLP. ·         Required to drive compliance with our Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. ·         Required to comply with our Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. ·         Ensure that all Quality Systems within the department are adhered to on a daily basis. ·         Operate as part of the QC team performing the allocated testing and laboratory-based duties. ·         Ensure timely completion of all assigned data processing and reviewing. ·         Ensure timely completion of Laboratory Investigation Reports and deviations through site procedures. ·         Participate in the timely generation of trend data, investigations, nonconformances, validation protocols, reports in support of method validation/verifications and equipment qualifications. ·         Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc. ·         Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved. ·         Review, approve and trend test results where applicable, ·         Participate in the laboratory aspects of OOS investigations. ·         Provide support with audit/inspection requirements to ensure department compliance/readiness. ·         Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why's etc, ·         May be required to perform other duties as assigned.   Experience, Knowledge & Skill: ·         Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices. ·         Knowledge of cGMP ·         Laboratory Quality Systems experience ·         Proficiency in Microsoft Office and job-related computer applications required ·         Report, standards, policy writing skills required ·         Understanding of Lean Six Sigma Methodology preferred. ·         Immunoassay and cell culture experience preferable ·         Great communicator, decisive decision-maker with a proven ability to deliver excellence ·         Ability to participate in highly effective teams. ·         Desire to continuously learn, improve and develop. ·         Willingness to support the team and a strong focus on delivering excellence. ·         High personal integrity, credibility, energy and flexibility.   Qualifications & Education: ·         Bachelor’s Degree or higher preferred; ideally in a science related discipline. #LI-AP1