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About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

Job Description:

We are searching for the best talent for the Quality Control Analyst role to be in Cork, Ireland.

Purpose:

The QC analyst role is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at Janssen Sciences Ireland (JSI) as required by Good Manufacturing Practice (GMP). Partners with other departments to ensure that all QC testing activities are completed in an efficient manner.

You will be responsible for:

• Achieves competency in laboratory methods and procedures.
• Trains other QC analysts in laboratory methods and procedures when required.
• Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.
• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and its associated software.
• Writes, executes, reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.
• Performs routine and non-routine analytical testing activities.
• Review and approval (where appropriate) of laboratory test results.
• Ensures that testing and results approval are completed within agreed turnaround times.
• Writes and reviews laboratory TMs, SOPs, TMDs and WIs as directed by company policy.
• Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
• Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Specialist, QC Team Leader and Manager.
• Deals with Quality Issues in an accurate and timely manner.
• Maintains and develops knowledge of analytical technology as well as cGMP standards.
• In process control testing and activities to support the production units.

Qualifications / Requirements:

• A third level qualification of a scientific/technical discipline is required.
• A minimum of 2 years’ experience in a laboratory-testing environment within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
• Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.

Key Individual Contributor Competencies

• Facilitate an environment of continuous improvement
• Collaboration and teamwork
• Strategic Thinker
• Credo value of integrity
• To work as a strategic partner with all other departments within the company
• Interface with all site departments as required.
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Innovative
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible

Significant Environmental, Health and Safety Considerations

• All employees are required to comply with the requirements of the company’s Environmental Health and Safety Policy, Safety Statement, associated EHS Procedures and local legislation.
• Take reasonable care to protect his or her own and the safety of their colleagues who may be affected by their actions.
• Comply with EHS rules and procedures always.
• Understand the potential EHS impact of their activities.
• Attend and participate in EHS training as required.
• Use PPE and safety equipment as required.
• Report all incidents, accidents, and near miss events.
• Report unsafe plant, equipment, acts, procedures or issues.
• Make suggestions to improve health and safety in the workplace.
• Actively participate in work area EHS teams.
• Not turn a ‘blind eye’ to unsafe acts or situations

IMPORTANT

This position description is a general guideline for colleagues; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.

Join us in shaping the future together—apply now and take the next step in your career with us! #RPOAMS

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