Senior Analyst, Laboratory QC

• Execute analysis of raw materials, in-process material, and finished product in compliance with schedule.
• Complete analysis in accordance with SOP and standard methods.
• Calculation of results and reporting of data, including trend analysis as required.
• Execute analysis of water, cleaning samples etc as required.

• Execute calibrations and PM of equipment as required to ensure equipment is appropriate for use for analysis.
• Co-ordinate maintenance schedules with external suppliers to ensure compliance with schedule and in house procedures.
• Preparation of all solutions, reagents etc. associated with analysis.
• Execute stock control on laboratory consumables including reagents, solvents to ensure there is adequate supply to execute tasks. Complete purchase orders as required and manage materials on receipt.
• Participate in the preparation of QC documents including SOPs, specifications, methods.

• Participate in training and development activities to ensure that new technologies are applied and that skill level is developed.
• Execute validation studies and transfer studies to ensure equipment, methods and personnel are appropriately qualified.
• Participation in QC and site projects by representing QC so as to provide an appropriate service to other departments.

• Ensure QC activities are executed in line in in-house procedures and in compliance with requirements of cGMP.
• Ensure QC activities are executed in line with safety requirements and good laboratory practice.
• Keep work area clean and tidy.
• Keep up to date on regulatory development and standards by accessing in house library, accessing current Pharmacopoeias etc.
• Participation in investigations into failures, out of trends and out of specifications as required ensuring follow up, following anomalies, failures and external compliance, ensuring corrective actions are implemented

• By reporting and communication to QC supervisor and or manager in timely fashion any events or incidents.
• By participation in preparation of QC reports.
• By completing checking of data to ensure accuracy and compliance.

• Allocation of work to the QC staff to ensure schedule adherence when required.
• Maintain and develop skills to ensure a multi-task team
• Delegation of QC Supervisor

• Degree in an analytical science is preferred
• Minimum 2 years experience in a laboratory environment. Direct experience of HPLC analysis would be an advantage
• Analytical approach to tasks. Good organisation skills. Technical skills in analysis are important. Knowledge of QC regulations. Knowledge of EU and FDA regulations.
• Good organisational and time management skills
• Judgement, initiative, concern for excellence, providing direction, technical skill & competence, teamwork & problem analysis.

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