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Associate Scientist QC LS
Requisition ID: 1805643761W
Role: Associate Scientist QC LS (QC Specialist – Laboratory Services)
Location: Ringaskiddy Cork, Ireland
Reports to: Manager QC - Lab System User BioCork 2
Janssen Sciences Ireland UC, (previously Janssen Biologics), is part of the Johnson & Johnson family of companies, the world’s most comprehensive and broadly-based manufacturer of healthcare products and related services. Our site in Ringaskiddy was established in 2005 on a 100-acre site with an investment of €500 million. We manufacture a range of biopharmaceutical products indicated for the treatment of conditions that include rheumatoid arthritis, psoriasis and cancer.
We are expanding our site to allow us to meet the critical needs of patients around the world. The expansion plans involve an investment of more than €300 million that will increase the existing manufacturing space by an additional 19,100m2, provide employment for up to 450 people during construction and an extra 200 people once completed.
We have an exciting opportunity for an Associate Scientist QC LS (QC Specialist – Laboratory Services) to join our expanding team in Cork to help support this expansion.
The Associate Scientist QC LS (QC Specialist – Laboratory Services) will be responsible for the following.
•Developing and qualifying the electronic data management processes for the QC team
•Administrating and maintaining Laboratory electronic systems
•Supporting equipment lifecycle management
•Supporting the monitoring and management of service providers
You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.
What you’re great at:
•Strong analytical skills
•Excellent communication, written and oral
•Acute attention to detail
•Adaptable and flexible
•Excellent team player with strong customer focus
•Knowledgeable of FDA/EMEA regulatory requirements
As an Associate Scientist QC LS (QC Specialist – Laboratory Services), your typical day may include:
•Administrate and maintain QC Laboratory systems such as eLIMS, LES, Empower 3, SDMS and Softmax Pro
•Providing day to day operational & training support for laboratory systems
•Completion of necessary software systems documentation reviews including periodic reviews, data integrity reviews and SOP updates.
•Creating and managing Empower projects, user accounts, instrument methods, method sets, report methods and processing templates
•Interacts and represents the Cork site on Global COEs related to laboratory systems.
•Ensure laboratory systems are compliant with the data integrity requirements of all applicable regulatory guidelines
•Developing/Monitoring performance metrics and implementing improvements from services providers including cost, safety, response speed etc.
•Supports the Management of service contracts and scheduling vendor visits.
•Supports Equipment lifecycle management – including appropriation, qualification, and maintenance and decommissioning.
•Supports change control, risk assessments, and capital requests for new analytical technologies and services.
•Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc
•Anticipates and plans for future requirements in the area.
•Deals with events/ deviations in an accurate and timely manner.
•Identifies opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc.
•Supports QC where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
•Deputizes for the supervisor and other ream members as appropriate.
•Collaborates across multiple lab groups and with other Janssen sites
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 3 years’ experience in a similar role within a laboratory environment
•Excellent social and communication skills
•Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project lifecycle and other regulatory requirements or policies
•Self-driven and keeps up to date with regulatory, technical developments within the industry.
•Focus on patients and customers at all times.
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
We respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. 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)