Quality Control Microbiologist

About PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in ****, 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:Reporting to the Microbiology Lead, this role will provide online QC oversight to Drug Substance/ Drug Product manufacturing operations.This is a crucial role within the Quality organisation with responsibility for directly supporting the manufacturing operations team on a daily basis, ensuring compliance with cGMP and corporate and local SOPs.Shift Pattern: Day shift 7am to 7pm shift pattern.This covers weekends.Responsibilities:Provide QC support to technology transfer and commercial manufacturing operations.Perform QC review of SOPs, risk assessments, change controls and other documentation, as applicable, associated with DS/DP manufacturing operations.Participate on microbiology projects, including microbial method validation and testing, environmental monitoring, microbial organism identification, supporting facility qualification, cleaning validation, and process validation.Perform microbial testing and participate with atypical/OOS investigations, change controls, and CAPAs.Work with supervisors and other team members to review and monitor method performance.Author of technical documents including methods protocols, qualification / validation protocols and reports, SOPs, etc.Provide technical guidance, as well as evaluate / introduce new technologies in microbiology area.Assist Microbiology Lead to develop micro control strategies, quality enhancement, and operational efficiency improvement.Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.Ability to work in a team environment and independently as required.Perform job specific tasks in compliance with applicable Regulations, International Standards, and Policies and Standard Operating Procedures.Other duties as assigned.Lead or participate on microbiology projects, including microbial method validation and testing, environmental monitoring, microbial organism identification, supporting facility qualification, cleaning validation, and process validation.Perform microbial testing and participate with atypical/OOS investigations, change controls, and CAPAsWork with supervisors and other team members to review and monitor method performance.Author of technical documents including methods protocols, qualification / validation protocols and reports, SOPs, etc.Provide technical guidance, as well as evaluate / introduce new technologies in microbiology area.Assist Microbiology Head to develop micro control strategies, quality enhancement, and operational efficiency improvement.Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development.Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.Ability to work in a team environment and independently as requiredPerform job specific tasks in compliance with applicable Regulations, International Standards, and Policies and Standard Operating Procedures.Thorough understanding of current Good Manufacturing Practices (GMP)Other Requirements:Knowledge of microbial testing and microbial control.Familiar with requirements of FDA and EMA regulations.Thorough understanding of current Good Manufacturing Practices (GMP)Excellent interpersonal and written and verbal communication skillsExcellent planning & organisational skillsComfortable in a fast-paced working environmentAble to adjust workload based upon changing prioritiesDemonstrated ability to work well in cross-functional teamsResults and solutions focusedDemonstrated experience within highly regulated environment.Ability to interpret technical documentation.knowledge of cGxP requirements and regulations.Knowledge of trouble shooting and problem-solving skills, e.g., formal root cause analysis such as Ishikawa diagrams, FMEA etc.Education:BSc in Microbiology or related field.1 – 3 years related industry experience