Senior Analyst, Laboratory Quality Control

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. 

We are looking for a Senior QC Analyst for our growing manufacturing site in Carrigtwohill , Co Cork.( Shift position and a 12 month FTC ) 

Responsibilities include:

Analysis of materials:

• 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.

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.
• 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.

Ensure appropriate procedures are in place by preparation and review of SOP’s, 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.
• Participation in QC and site projects by representing QC so as to provide an appropriate service to other departments.

Meet the Quality and Safety standards:

• 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

Reporting and communication:

• 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.

Providing support to QC Supervisors:

• 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.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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