QC Microbiologist is required for a new purification and aseptic manufacturing plant for the blood protein albumin at Grifols Worldwide Operations (GWWO). 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.
Reporting to the Quality Control Microbiology Supervisor of Grifols Worldwide Operations (GWWO).
·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 and qualified appropriately.
·Ensure laboratory equipment and services maintained in an operational (and safe) state.
·Participate in the verification, validation and technical transfer of microbiological and analytical testing procedures.
·Ensure that all cGMP, company specifications, procedures and guidelines are followed. ·Investigate Out of Specification (OOS) and Out of Trend (OOT) results as required.
·Investigate Deviations and actively lead subsequent corrective actions as required.
·Participate in and responsible for QC related CAPA's.
·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 maybe 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.
·Ensures area of responsibility is maintained in a state of compliance and audit readiness.
·Maintain current knowledge of regulatory and industry standards, trends and advancements through independent reading and training.
·Flexibility and willingness to carry out shift work when required.
· Knowledge of and proficiency in a wide array of current microbiological techniques. · Knowledge of and proficiency in the use of analytical instruments including troubleshooting skills.
· Ability to carry out a wide array of Standard Operating Procedures.
· Experience with investigating and determining root cause of Out of Specification and Out of Trend events and writing thorough reports regarding the investigational findings. · Interpret and apply applicable regulatory guidelines.
· Excellent verbal and written communication. Must be able to read, write, and speak English.
· Must have strong technical writing skills.
· Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
· Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
· Bachelor's degree in Microbiology, Biochemistry or closely related scientific field.
· Requires a minimum of 2 years of related experience.
· Experience in method transfer and verification/validation.
· Experience in statistical analysis including use of Minitab.
· General knowledge of pharmaceutical plasma-derivative company process, equipment and their microbiological control.
· Strong knowledge of analytical techniques for biologics or protein-based therapeutics
For more information Contact Ann Marie Corcoran