QC Microbiologist

Employer
Grifols
Location
Dublin, Dublin West
Salary
EUR40000 - EUR60000 per annum + bonus, health insurance , 25 days hols
Closing date
20 Apr 2021

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Sector
Manufacturing
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Job Details

 

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.

 

 

 

 

 

Company

Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction. www.grifols.com

Grifols Plant

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Location
Ireland

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