QC Scientist

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Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Ringaskiddy, Cork, Ireland

Job Description:

J&J IM is recruiting for a  QC Scientist within the Quality department and to be based in Cork (Ireland).

POSITION SUMMARY:

This position is responsible for carrying out tasks and projects related QC Microbiological

activities at Janssen Sciences Ireland UC (JSI) as required by Good Manufacturing

Practice (GMP).

Partners with other departments to ensure that all QC Microbiology

testing activities are completed in an efficient manner.

GENERAL SCOPE OF RESPONSIBILITIES:

• Achieves proficiency in JSI microbiology laboratory methods and procedures.

• Supports investigational microbiological testing activities during complex

investigations while managing the communication flow of QC data within QC to

Operations.

• Ensures that testing and results approval are completed within agreed

turnaround times.

• Performs Microbiological testing activities in relation to method validation and

technical transfer activities.

• Executes validation, operation, maintenance, calibration and troubleshooting of

equipment and its associated software.

• Executes and reviews IQ/OQ and PQ protocols so as to ensure that all relevant

equipment is qualified for cGMP use.

• Writes and reviews laboratory TMs, SOPs and WIs as directed by company

policy.

• Ensures QC activities are carried out in compliance with product licence

commitments, cGMP and company quality standards.

• QC Micro data collating, trending analysis and reporting.

• Change management SME for QC Microbiology.

• Is an active member of the QC Technical Team supporting and providing

guidance to the QC microbiology group and provide assistance with other group

activities as required and communicates relevant issues to the QC Team Leader

and Manager.

• Anticipates and plans for future requirements in the area.

• Deals with non-conformances/ deviations in an accurate and timely manner.

• Deputizes for the QC Technical Team Leader as appropriate.

• Maintains and develops knowledge of analytical technology as well as cGMP

standards.

• Identify and implement new technologies in addition to supporting the validation

and filing requirements for the identified new technologies.

• Ownership of the Microbial Control strategy.

KEY COMPETENCIES REQUIRED:

• Collabor...