QC Analyst

Job Description

Job Title: QC Analyst

Location: Ireland - Cork Co., Currabinny, Carrigaline

Shift: Mon - Fri 8:30am - 4:45pm

Fixed Term of 1 year

Job Purpose

The purpose of this job is to provide high quality analytical support to the Operations team and other internal customers.  To promote and monitor laboratory GMP/Safety within the Laboratory such that the Quality Control laboratory is maintained an inspection ready state.  To actively participate in the development of the Laboratory as a centre of excellence.

Accountability:

Routine Analysis

• Carry out receipt of samples onto the LIMS system and label samples with LIMS Label.
• Prepare composite samples and export samples (Finished Products) of materials where necessary.
• Prepare and file Batch Analytical packages.
• Prepare and store Retention samples as required in accordance with local SOP.
• Communicate to the Laboratory Leader regarding any sample issues.
• Perform routine analysis of raw materials, intermediates, final products and other miscellaneous samples.  Turnover of samples should be carried out in strict compliance with established laboratory GMP practices.
• Ensure that the Visual Workplace metrics for the Laboratory are achieved as part of Performance Management.
• Carry out OOS laboratory investigations in compliance with appropriate SOP and communicate any batch failures/atypical results to Senior Shift Analyst/Laboratory Leader.
• Communicate effectively with internal customers as required.
• Report progress/key issues to QC Laboratory Leader.

Laboratory GMP Compliance

• Obtain a working knowledge of all relevant site and analytical Standard Operating Procedures
• Maintain laboratory notebooks and appropriate testing sheets in compliance with GMP requirements.
• Participate in the laboratory’s calibration programme, as required.
• Participate in Management of Reference Materials, as required.
• Carry out calibration of equipment and inspection of laboratory balances. As required, carry out a review of HPLC instrument performance and report as required.
• Ensure that the validation/calibration documentation associated with instrumentation is appropriately signed off before use.
• Maintain good housekeeping standards. This should include use of housekeeping labels, buffer, reagents, mobile phases labelling etc. Carry out internal laboratory audits at the designated frequency and report any deficiencies.  
• Maintain individual training records on an ongoing basis. Participate in the training of team members as appropriate.
• Carry out and report internal team audits, as appropriate.
• Complete assigned tasks and CAPAs as required.
• Raise purchase requisitions on SAP as required.
• Equivalency testing as per an agreed protocol. Equivalency testing should be carried out as per the protocol and within the agreed timelines. File and archive all data including raw data.

Interpersonal Skills:

• Good communication, organizational and interpersonal skills.
• Good facilitation and presentation skills.
• Innovative, with the potential for scientific leadership.
• A good team player, able to work confidently in teams in a multi-disciplinary environment and communicate with customers.
• Positive, can-do approach and enthusiasm.

Problem Solving:

Ability to use problem solving tools such as RCAs to solve problems in lab investigations, quality investigations.  Also, be able to participate in cross functional investigation teams.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.