QC Analyst II

We are looking for a QC Analyst II – Environmental Monitoring (EM) to join a growing Quality Control team supporting GMP manufacturing operations. This role will primarily focus on Environmental Monitoring (EM) activities, ensuring manufacturing environments meet the highest standards of quality and regulatory compliance. Working within a fast-paced CDMO environment, you will perform environmental monitoring, review data and trends, support laboratory investigations, and collaborate closely with Manufacturing, Quality Assurance, and Development teams. This is an excellent opportunity for someone with a strong microbiology or environmental monitoring background looking to further their career in Quality Control. Key Responsibilities Perform routine Environmental Monitoring (EM) sampling and testing throughout GMP manufacturing areas. Review EM results, analyse trends, and generate monitoring reports. Perform growth promotion testing of microbiological media. Conduct sampling and testing of Water for Injection (WFI) and clean steam systems. Support raw material testing activities as required. Record, review, and maintain laboratory data in accordance with cGMP and GDP requirements. Participate in laboratory investigations, including deviations and Out of Specification (OOS) events. Assist with troubleshooting laboratory issues and support continuous improvement initiatives. Author and revise SOPs, test methods, protocols, reports, and other controlled documentation. Collaborate with Manufacturing, Quality Assurance, Development, and Project Management teams. Communicate testing results, quality issues, and project updates effectively to key stakeholders. Maintain accurate laboratory documentation and ensure compliance with quality systems. Requirements Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific discipline. 3+ years of experience in a GMP Quality Control laboratory. Hands-on experience performing Environmental Monitoring within a GMP manufacturing environment. Experience with microbiological techniques and environmental monitoring programmes. Strong understanding of cGMP, GDP, and quality system requirements. Experience supporting laboratory investigations, deviations, and continuous improvement initiatives. Previous experience within a CDMO/CMO environment is highly desirable. Excellent documentation practices and commitment to data integrity. Strong problem-solving, analytical, and organisational skills. Ability to manage multiple priorities in a fast-paced environment. Strong written and verbal communication skills. #J-18808-Ljbffr