Johnson & Johnson Careers
Associate Scientist QC NPI
Requisition ID: 1805665978W
Role: Associate Scientist QC NPI (QC specialist)
Location: Ringaskiddy Cork, Ireland
Reports to: NPI 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.
What you’re great at:
As an Associate Scientist QC NPI, your typical day may include:
- Uses expertise and acts as a single point of contact in the introduction of new products, technologies, and/or processes within QC department & for QC NPI onsite
- Participates in technical groups to implement laboratory activities, and solve complex problems, while complying with local and global regulatory requirements as well as J&J standards.
- Creation of documentation for new product introduction to QC department e.g. gap analysis, validation/verification protocols, validation/verification reports, test method updates.
- Management of product lifecycle e.g. Annual Product review (APR) documents, CPV (Continued Process Verification) documents, Data gathering, follow up investigations.
- Trains/mentors other colleagues in expertise area and develops training material to enable sharing of knowledge and expertise with teams, in multiple forums.
- Project support, coordination & executions within and between sites.
- Collaborates within and across sites and with key stakeholders or partner functions e.g. OneLab COE’s, Regulatory Affairs, Site NPI function.
- Supports the network in responding to health authority queries
- Proactively seeks development and growth in NPI and project management.
To be part of this high performing team you will have great attention to detail, alongside
•BSc Hons (or Higher) in a Science or related discipline.
•A minimum of 4 years’ relevant experience
•Acute attention to detail
•Focus on patients and customers at all times
•Expertise troubleshooting process non-conformances, out-of-specification test results, and failure investigations
•Solid understanding of, and ability to interpret, applicable regulatory agency regulations, cGMPs and industry standards, and maintains currency on pharmacopeia compendia
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)