Qc Microbiology Analyst

Orion Group Life Sciences are currently recruiting aQC Microbiology Analyston behalf of our Multinational Biopharmaceutical Client based in Dundalk on an initial 11-Month contract with potential to extend.Shift Pattern: Day shift 7am to 7pm shift patternProvide 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.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 the Vaccines Policies and Standard Operating Procedures.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.Ability to work in a team environment and independently as requiredThorough understanding of current Good Manufacturing Practices (GMP)EducationBSc in Microbiology or related field.1 – 3 years related industry experience.Work ExperienceDemonstrated 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.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 focusedOur role in supportingdiversityandinclusionAs an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group.We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion.In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.