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QC Scientist (Micro) - 2406184180W

Description

"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo (https://www.jnj.com/credo/)

QC Scientist (Micro) (m/f/d)

Location: 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 competency in JSI microbiology laboratory methods and procedures.

• Performs routine and investigational microbiological testing activities.

• Review and approval (where appropriate) of laboratory test results.

• Ensures that testing and results approval are completed within agreed turnaround times.

• Trains other QC analysts in Microbiology laboratory methods and procedures when required.

• 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 license 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 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 Team Leader as appropriate.

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

Qualifications

KEY COMPETENCIES REQUIRED:

• Collaboration and teamwork.

• Strategic thinker.

• Problem solving and attention to detail.

• Results and performance driven.

• Coaching 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.

• Builds 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 other’s ideas.

• Maintains the highest standards of ethical behavior.

• 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.

• 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.

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.

What we offer

Our employees are just as important to us as our customers. At Johnson & Johnson, we like to think long-term and enable successful careers with interesting career paths within our company. We do everything we can to enable you to develop your full potential with us.

We are very proud of our open, appreciative corporate culture and value a healthy balance between work, family and leisure. Flexible working time models such as part-time, flexible time and home office can be adapted to your life. Our proactive health program and our company fitness center take care of your mental and physical well-being.

Working at Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Primary Location Europe/Middle East/Africa-Ireland-Cork-Cork

Organization Janssen R&D Ireland (7566)

Job Function Quality Control

Req ID: 2406184180W