Microbiologist

QC Microbiologist

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).

Responsibilities

• 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.

Requirements

• 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

Desirable Requirements

• 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.