Johnson & Johnson Careers
Requisition ID: 1805689049W
Role: QC Analyst x 3
Location: Ringaskiddy Cork, Ireland
Reports to: QC Team Leader
Janssen Sciences Ireland UC established its operation in Ringaskiddy in 2005 on a 100 acre site with an investment of €500 million. For more than 25 years we have been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
The facility in Ringaskiddy is operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.
In 2017, Janssen Sciences Ireland UC announced that it is to invest more than €300 million in the expansion of its manufacturing plant that will create more than 200 new jobs.
A QC Analyst is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at CBIL as required by Good Manufacturing Practice (GMP). Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.
What you’re great at:
As a QC Analyst, your typical day may include:
• Achieveing competency in CBIL 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 so as to ensure that all methods meet ICH, CFR 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 so as 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 and WIs as directed by company policy.
• Ensures QC activities are carried out in compliance with product licence 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 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.
To be part of this high performing team you will have great attention to detail, alongside:
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.
KEY INDIVIDUAL CONTRIBUTOR COMPETENCIES:
. 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
. Holds self accountable for compliant and flawless execution
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each:
Committed to caring
Responsible to our communities
Ready to apply our knowledge and know-how
Rare in our background and experiences
The drivers of our own success
Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your real passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting www.careers.jnj.com
If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Janssen R&D Ireland (7566)