QC Microbiologist

Grifols

Dublin, Ireland

Posiition Summary

Quality Control (QC) Microbiologist for the purification and aseptic manufacturing plant at Grifols Worldwide Operations (GWWO), reporting to the QC Microbiology Manager.

This role offers a chance to work in a state-of-the-art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.

What you'll do

Purified Water, Water for injection and clean steam microbiological bioburden (TVC) and Endotoxin (LAL) analysis. Additional analytical testing as required;
Carry out environmental monitoring including Viable/non-viable particles monitoring in manufacturing facilities as required;
Carry out in-process and finished product microbiology analysis including Total Viable Count (TVC), microbial ID, sterility, and Endotoxin testing as required;
Ensure laboratory processes, equipment and services are installed, qualified and maintained appropriately;
Participate in the verification, validation, and technical transfer of microbiological and analytical testing procedures;
Ensure that all cGMP, company specifications are procedures are followed;
Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required;
Participate in and responsible for QC related CAPAs;
Adhere to QC documentation system and prepare and review document change requests as required;
Develop, improve, and implement QC procedures, processes, and systems;
Support projects and continuous improvement initiatives within the Quality department and other functional areas;
Participate in international project teams relating to QC and wider quality activities and travel may be required;
Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy, and safe at all times;
Prepare for and support regulatory and internal inspections/audits;
Provide hands-on guidance and training when needed;
Ensure work area is maintained in a state of compliance and audit readiness;
Flexibility and willingness to carry out shift work when required.

What you'll bring

Knowledge of and proficiency in a wide array of current microbiological techniques;
Knowledge of and proficiency in the use of analytical instruments;
Experience with investigating and determining root cause of Out of Specification and Out of Trends;
Excellent verbal and written communication. Must be able to read, write, and speak English;
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner;
Strong organizational, analytical, and problem-solving skills;
Knowledge of sterility failure investigation desirable;
Experience with SAP desirable;
Experience in method transfer and verification/validation desirable;
Knowledge of analytical techniques for biologics or protein-based therapeutics desirable but not essential.