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).
· 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.
· 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.
· Fluent in both written and spoken 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.
- 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.
For more information Contact Ann Marie Corcoran