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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).
- Purified Water, Water for injection and Clean steam microbiological bioburden (TVC) and Endotoxin (LAL) analysis. Also analytical testing including pH, Conductivity, Total Organic Carbon (TOC) and chemistry 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 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.
- 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.
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