Senior QC Microbiology Associate

Job Description: Senior QC Microbiology AssociateAscendPM is supporting a leading global biopharmaceutical organisation based in South Dublin. The site specialises in the manufacture and supply of high-quality biologic medicines within a highly regulated cGMP environment.We are currently seeking a Senior QC Microbiology Associate to join the site’s Quality Control team on a 12-month contract. The Senior QC Microbiology Associate will perform microbiological testing and environmental monitoring activities in support of aseptic manufacturing operations.The role will involve environmental monitoring across classified cleanrooms, RABS and isolator environments, alongside water, bioburden, in-process and biological indicator testing. The successful candidate will work with a high degree of independence while ensuring all activities are completed in accordance with approved procedures, cGMP requirements and data integrity standards.Key Responsibilities:Perform environmental monitoring within Grade 5, 7, 8 and 9 classified cleanroom environments.Conduct environmental monitoring of RABS and isolator systems.Read, assess and document environmental monitoring plates.Perform bioburden testing of water and disinfectant samples.Conduct routine water sampling and associated microbiological testing.Test in-process samples, including pH testing.Perform testing of biological indicators.Prepare technical documentation, including monthly and annual environmental monitoring trend reports.Review and audit laboratory documentation and operational processes to ensure compliance.Accurately document testing activities in accordance with cGMP, GxP and data integrity requirements.Use laboratory and quality systems such as LIMS, LMES, TrackWise, SAP and CDOCS.Identify, troubleshoot and escalate technical or compliance issues as required.Manage changing priorities while maintaining accurate, right-first-time results.Work independently under minimal supervision and deliver assigned activities within agreed timelines.Support regulatory inspections and interact with inspectors or regulatory agencies where required.Contribute to continuous improvement, change control and wider QC Microbiology activities.Demonstrate leadership and effective communication when working with colleagues and cross-functional stakeholders.Skills & Experience:Bachelor’s degree in Microbiology, Biology or another relevant scientific discipline.Previous biopharmaceutical Quality Control experience within a microbiology laboratory.Hands-on experience performing environmental monitoring in an aseptic or classified cleanroom environment.Strong technical knowledge of microbiology, aseptic manufacturing and contamination-control principles.Experience supporting the manufacture and testing of pharmaceutical or biopharmaceutical products in a cGMP-regulated environment.Working knowledge of GxP requirements and data integrity principles.Experience with LIMS and laboratory execution systems is strongly preferred.Experience with Change Control, TrackWise, SAP or CDOCS would be advantageous.Experience preparing environmental monitoring trend reports or other technical QC documentation.Previous involvement in regulatory inspections or interaction with regulatory inspectors would be beneficial.Strong problem-solving skills with the ability to recognise and escalate issues appropriately.Demonstrated ability to work independently, manage competing priorities and consistently deliver right-first-time results.Strong leadership, communication and interpersonal skills.Flexibility to work within a fast-paced environment where operational priorities may change daily.Contract InformationRate: TBC dependent on level of skills and experience of the Candidate.Start Date: ASAP.Length of Contract: 12 months.Location: South Dublin.Working Arrangements: Full time on site.Schedule: 24/7 Shift Pattern – Potential extended working hours also.Work Authorisation: Candidates must hold valid authorisation to work in Ireland.