Senior Analyst, Laboratory Quality Control

AbbVie - Norfolk, VA

Full-time - Mid Level

Norfolk, VA

Chemical Manufacturing

About the position

AbbVie is seeking a Senior Quality Control (QC) Analyst for its manufacturing site in Carrigtwohill, Co Cork. This position is critical in ensuring that all materials, including raw materials, in-process materials, and finished products, are analyzed in compliance with established schedules and standard operating procedures (SOPs). The Senior QC Analyst will be responsible for executing various analyses, including water and cleaning samples, and will ensure that all results are calculated and reported accurately, including trend analysis as required. In addition to analysis, the role involves routine maintenance of QC systems, including the calibration and preventive maintenance (PM) of equipment to ensure it is suitable for use. The analyst will coordinate maintenance schedules with external suppliers and prepare all necessary solutions and reagents for analysis. Stock control of laboratory consumables is also a key responsibility, ensuring that there is an adequate supply of reagents and solvents, and managing purchase orders upon receipt of materials. The Senior QC Analyst will participate in the preparation of QC documents, including SOPs, specifications, and methods, and will ensure that appropriate procedures are in place through the preparation and review of these documents. Training and development activities will be part of the role to ensure that new technologies are applied effectively and that the skill level of the team is developed. The analyst will also execute validation and transfer studies to ensure that equipment, methods, and personnel are appropriately qualified. Meeting quality and safety standards is paramount, and the Senior QC Analyst will ensure that all QC activities comply with cGMP requirements and safety protocols. Keeping the work area clean and up to date with regulatory developments is essential. Participation in investigations into failures and out-of-trend results will be required, ensuring that corrective actions are implemented. Effective reporting and communication with the QC supervisor and manager are crucial, including timely reporting of any incidents and participation in the preparation of QC reports. The Senior QC Analyst will also support QC supervisors by allocating work to QC staff to ensure adherence to schedules and maintaining a multi-tasking team environment.

Responsibilities

• Execute analysis of raw materials, in-process material, and finished product in compliance with schedule.
• Complete analysis in accordance with SOP and standard methods.
• Calculate results and report data, including trend analysis as required.
• Execute analysis of water, cleaning samples, etc. as required.
• Carry out routine maintenance activities for QC systems.
• 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.
• Prepare 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.
• Ensure appropriate procedures are in place by preparation and review of SOPs, methods, and specifications.
• 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.
• Participate in QC and site projects by representing QC to provide an appropriate service to other departments.
• Ensure QC activities are executed in line with 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.
• Participate in investigations into failures, out of trends, and out of specifications as required, ensuring follow-up and corrective actions are implemented.
• Report and communicate to QC supervisor and/or manager in a timely fashion any events or incidents.
• Participate in the preparation of QC reports and complete checking of data to ensure accuracy and compliance.
• Provide support to QC Supervisors by allocating work to the QC staff to ensure schedule adherence when required.

Requirements

• 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 with good organization skills.
• Technical skills in analysis are important.
• Knowledge of QC regulations and EU and FDA regulations.
• Good organizational and time management skills.
• Judgement, initiative, concern for excellence, providing direction, technical skill & competence, teamwork & problem analysis.