QC Microbiology AnalystThe QC Microbiology Analyst will provide online QC oversight to Drug Substance/ Drug Product manufacturing operations This role is an 11 month contract with extended days shift which will include some 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.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.Required:BSc in Microbiology or related field years related industry experience.Demonstrated experience within highly regulated environment.ability to interpret technical documentation.knowledge of cGxP requirements and regulations.Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at or send your CV to-