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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 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
Qualifications:
Bachelor’s degree in Microbiology, Biochemistry or closely related scientific field.
Requires a minimum of 2 years of related experience.
Our Benefits Include:
Highly competitive salary
Annual performance based bonus %
Shares options scheme
Group pension scheme - Contribution rates are (3%/ 5%/ 7%) and company will match
Private Medical Insurance for the employee
Ongoing opportunities for career development in a rapidly expanding work environment
Succession planning and internal promotions
Education allowance
Wellness activities - Social activities eg. 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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Location: Grange Castle International Business Park, Grange, Clondalkin, Co. Dublin, D22 K2R3
Learn more about Grifols
