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QC Microbiologist

1 month ago

Dublin, Dublin City, Ireland Grifols, S.A Full time

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

At Grifols, we believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

Quality Control (QC) Microbiologist is required 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.

KEY RESPONSIBILITIES:
  1. Purified Water, Water for injection and Clean steam microbiological bioburden (TVC) and Endotoxin (LAL) analysis. Also analytical testing as required.
  2. Carry out environmental monitoring including Viable/non-viable particles monitoring in manufacturing facilities as required.
  3. Carry out in-process and finished product microbiology analysis including Total Viable Count (TVC), microbial ID, sterility and Endotoxin testing as required.
  4. Ensure laboratory processes, equipment and services are installed, qualified and maintained appropriately.
  5. Participate in the verification, validation and technical transfer of microbiological and analytical testing procedures.
  6. Ensure that all cGMP, company specifications are procedures are followed.
  7. Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
  8. Participate in and responsible for QC related CAPA's.
  9. Adhere to QC documentation system and prepare and review document change requests as required.
  10. Develop, improve and implement QC procedures, processes and systems.
  11. Support projects and continuous improvement initiatives within the Quality department and other functional areas.
  12. Participate in international project teams relating to QC and wider quality activities and travel may be required.
  13. Adhere to safety standards to ensure a safe working environment while ensuring the laboratory is kept clean, tidy and safe at all times.
  14. Prepare for and support regulatory and internal inspections/audits.
  15. Provide hands-on guidance and training when needed.
  16. Ensure work area is maintained in a state of compliance and audit readiness.
  17. Flexibility and willingness to carry out shift work when required.
Knowledge & Skills
  1. Knowledge of and proficiency in a wide array of current microbiological techniques.
  2. Knowledge of and proficiency in the use of analytical instruments.
  3. Experience with investigating and determining root cause of Out of Specification and Out of Trends.
  4. Excellent verbal and written communication. Must be able to read, write, and speak English.
  5. Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
  6. Strong organizational, analytical and problem-solving skills.
  7. Knowledge of sterility failure investigation is desirable.
  8. Experience with SAP is desirable.
  9. Experience in method transfer and verification/validation is desirable.
  10. Knowledge of analytical techniques for biologics or protein-based therapeutics is desirable.
Our Benefits Include:
  1. Highly competitive salary.
  2. Group pension scheme - Contribution rates are 5% employer and 5% employee.
  3. Private Medical Insurance for the employee.
  4. Ongoing opportunities for career development in a rapidly expanding work environment.
  5. Succession planning and internal promotions.
  6. Wellness activities - Social activities e.g. Padel, Summer Events.

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply – we're excited to hear from you.

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