QC Chemistry Analyst

Location: 

Dublin, IE

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  472468

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Quality Control Chemistry Analyst

 

QC Chemistry Analyst 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 directly to the Quality Control (QC) Chemistry Supervisor of Grifols Worldwide Operations (GWWO).

 

Responsibilities

  • Carry out raw material, in-process and finished product chemistry and immunochemistry analysis.
  • In-process and finished product QC including protein and excipient analysis including analytical techniques such as Spectrophotometry, Immuno-electrophoresis, HPLC, GC, AA and Flame-photometry.
  • Raw material QC including Karl-Fischer, FT-IR and NIR techniques.
  • Testing carried out in relevant fumehoods / safety cabinets 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 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 Non-Conformances 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.

 

Requirements

  • Knowledge of and proficiency in a wide array of current analytical techniques including HPLC, Spectrophotometry and  Electrophoresis.
  • 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 Chemistry, Biochemistry or closely related scientific field. 
  • Requires a minimum of 2 years of related experience. 

Desirable

  • Knowledge of specific product analysis (e.g. IC, AA, GC, Flame-photometry and Kjeldahl techniques) is a distinct advantage.
  • Knowledge of raw material analysis (e.g. Karl-Fischer, FT-IR and NIR techniques) is a distinct advantage.
  • Experience with SAP.
  • Experience in method transfer and verification/validation.
  • Experience with statistical analysis including use of Minitab.
  • General knowledge of pharmaceutical plasma-derivative company process, equipment and their chemical control.
  • Strong knowledge of analytical techniques for biologics or protein-based therapeutics.

 

Location: EMEA : Ireland : Dublin:Grange Castle (Dublin) 

 

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