QC Chemistry Analyst

A QC Chemistry Analyst is required for a new purification and aseptic manufacturing plant
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 Manager.

KEY 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 maintained in an operational (and safe) state.
*Participate in the technical transfer / validation 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 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.


Qualifications

*Bachelor's degree in Chemistry, Biochemistry or closely related scientific field.


Knowledge & Skills

*Strong organizational, analytical and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
*Requires a minimum of 2 years of related experience.
*Knowledge of and proficiency in a wide array of current analytical techniques including HPLC, GC, AA, Spectrophotometry, electrophoresis, Flame-photometry, Karl-Fischer, FT-IR and NIR 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.


Contact Ann Marie Corcoran for more information