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Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
Responsibilities:
This position is responsible for carrying out tasks and projects related to 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.
* 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.
* 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 provides 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.
* Identifies and implements 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:
Collaboration and team work.
Strategic thinker.
Problem solving and attention to detail.
Results and performance driven.
Cooking and mentoring style.
Integrity, trustworthiness and objectivity.
Customer focus.
Clear communication skills.
Adaptable and flexible.
Innovative.
Inclusive, facilitative style.
Key Individual Contributor Competencies:
To work as a strategic partner with all other departments within the company.
Buids strong productive relationships.
Demonstrates ability to work with teams and individuals.
Asserts personal ideas and opinions using persuasion to influence others.
Seeks opportunities to grow and develop professionally.
Uses best practices to improve business operations.
Works effectively with people that have diverse styles, talents and ideas.
Attention to detail.
Good problem solving skills.
Interface with all site departments as required.
Excellent interpersonal skills.
Ability to operate as part of a team is critical.
Excellent communication skills both written and verbal.
Holds self accountable for compliant and flawless execution.
Takes personal responsibility for decisions that successfully build customer value.
Effectively manages and adapts to change.
Demonstrates the courage to stand alone on ideas and opinions that differ from others.
Listens effectively and remains open to others' ideas.
Maintains the highest standards of ethical behaviour.
Treats people with dignity and respect.
Qualifications and Experience:
A third level qualification in a scientific/technical discipline 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.
Note: A waiver may be granted in exceptional circumstances for individuals who are not performing those tasks requiring the above qualifications and experience. This would be at the discretion of the QC Team Leader in conjunction with QC Manager.
Desirable Qualifications and Experience:
Compliance with the cGMP, GMP, EHS, WWRIM, AE/PQC, IAPP and other local legal and/or regulatory requirements.
Strong technical knowledge in and experience with QC testing methods and equipment is required.
Proficient in using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint).
Be able to work independently with minimum supervision.
Cooperate efficiently with the different partners.
Significant Safety or Working Considerations:
All employees are required to comply with the requirements of the company's Environmental, Health & Safety Policy, Safety Statement, associated EHS Procedures, local legislation and duties outlined in the site EHS Manual. In line with the Safety Health & Welfare at Work Act (2005), all employees are required to:
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 at all times.
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.