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Associate Scientist QC
Requisition ID: 1805643535W
Role: Associate Scientist QC (QC specialist)
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 a Associate Scientist QC (QC Specialist) to join our expanding team in Cork to help support this expansion.
The Associate Scientist QC (QC Specialist) will be responsible for the following.
•Selection, procurement and qualification of analytical instrumentation
•Coordination of activities related to the successful introduction of new products to the QC Labs E.g. Transfer of Analytical Methods
•Coordination of sampling and testing related to the qualification of the new labs and manufacturing suites
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 (QC Specialist), your typical day may include:
•Analytical instrument selection, procurement and qualification
•Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc
•Plans and oversees lab related activities for the introduction of new products e.g. Analytical Method transfers.
•Reviews and approves product specifications and plans for associated LIMS builds.
•Oversees the QC requirements for in process, release and stability sampling and testing required from the manufacturing process.
•Provides technical input into QC related investigations during startup of the new areas and routine production.
•Generates, reviews and approves analytical data associated with equipment qualification, analytical method transfers and if required in process and release testing.
•Supports the generation, review and approval of data required for regulatory filings.
•Proactively identifies and drives lab process improvements.
•Supports the QC batch release process
•Trains laboratory team on specific laboratory processes and/or analytical technology.
•Provides superior technical support on specific analytical technology.
•Supports lean initiatives in the lab environment i.e. test method execution, documentation updates and equipment qualification etc.
•Presents technical/analytical data clearly and concisely to customers, i.e. internal investigations and regulatory inspectors etc.
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
•Excellent social and communication skills
•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
•Resposible 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)