QC Microbiology Technician

  • Carlow
  • Psc Biotech Ltd
Job Description 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 Microbiology Technician Role Description: We seek a QC Microbiology Technician to join our Quality team. You will perform day to day laboratory testing, data review, routine duties and be capable of enthusiastically taking responsibility for ad-hoc duties and projects. While working cooperatively as part of a team, you will demonstrate drive, initiative and hunger for knowledge and quality of work. You will also demonstrate the capability of being a Subject Matter Expert in several assays & ensure that laboratory objectives are effectively achieved consistent with company requirements to ensure compliance, safety and reliable supply to our customers. Requirements Requirements Role Functions: What you will do: Perform any assigned aspect of routine testing in support of manufacturing and batch release with high quality of documentation RFT and technical writing. Perform data review of microbiological test data from utilities and environmental monitoring samples. Other data review may be performed in line with experience level and SME knowledge. Clearly demonstrate the organisational skills to manage all aspects of a given assay e.g., controls/reference, standard stock control etc Ensure SOPs/forms are up to date with latest requirements and improvements/optimizations/lean. Support process simulations Work as part of a team Demonstrate awareness of safety for self and others in all aspects of work Understand analysis of data generated in the lab. Maintain laboratory housekeeping standards. Strong scientific and GMP documentation skills Understand Pharmacopoeias and company guidelines and how to find and follow relevant information. Comply with Global and regulatory Requirements and execute current good manufacturing practices (cGMP) in the performance of day-to-day activities and all applicable job functions May be required to perform other duties as assigned. Experience, Knowledge & Skills: What skills you will need: Knowledge of cGMP and GDP Laboratory Quality Systems Proficiency in Microsoft Office and job-related computer applications required Understanding of Lean six Sigma Methodology preferred High standard of quality Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers Focus on customers and patients. Demonstrate initiative. Make rapid, disciplined decisions. Focus on customers and patients. Collaborate Drive results Qualifications & Education: Bachelor’s degree preferred, ideally in science related discipline. Minimum of 1-2 years’ experience within the pharmaceutical industry (within Microbiology) – preferable in sterile manufacturing microbiology lab environment. #LI-KV2 Requirements Perform any assigned aspect of routine testing in support of manufacturing and batch release with high quality of documentation RFT and technical writing. Perform data review of microbiological test data from utilities and environmental monitoring samples. Other data review may be performed in line with experience level and SME knowledge. Clearly demonstrate the organisational skills to manage all aspects of a given assay e.g., controls/reference, standard stock control etc Ensure SOPs/forms are up to date with latest requirements and improvements/optimizations/lean. Support process simulations Work as part of a team Demonstrate awareness of safety for self and others in all aspects of work Understand analysis of data generated in the lab. Maintain laboratory housekeeping standards. Strong scientific and GMP documentation skills Understand Pharmacopoeias and company guidelines and how to find and follow relevant information. Comply with Global and regulatory Requirements and execute current good manufacturing practices (cGMP) in the performance of day-to-day activities and all applicable job functions May be required to perform other duties as assigned. Experience, Knowledge & Skills: What skills you will need: Knowledge of cGMP and GDP Laboratory Quality Systems Proficiency in Microsoft Office and job-related computer applications required Understanding of Lean six Sigma Methodology preferred High standard of quality Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers Focus on customers and patients. Demonstrate initiative. Make rapid, disciplined decisions. Focus on customers and patients. Collaborate Drive results