QC Microbiologist

Recruiter
Grifols
Location
Dublin, Dublin West
Salary
EUR40000 - EUR60000 per annum + bonus, health insurance , 25 days hols
Posted
23 Mar 2021
Closes
20 Apr 2021
Ref
QC Microbiologist
Contact
Ann Marie Corcoran
Sector
Manufacturing
Job Type
Permanent
Hours
Full-time

 

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.

 

 

 

 

 

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