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QC Team Leader
Requisition ID: 1805645042W
Role: QC Team Leader
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 experienced QC Team Leader to join our expanding team in Cork to help support this expansion.
The QC Team Leader will be responsible for the following.
•Managing a group of 10-15 QC Analysts and the QC activities associated with the startup of the new QC laboratories. This can include but is not limited to:
oOnboarding and training new analysts
oQualification of analytical equipment
oAnalytical Method Transfer
oSampling and testing coordination during plant and laboratory utility qualification.
oManages utility, raw material, in process and drug substance microbiology and QC sampling and testing.
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:
•Motivating and developing staff members
•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 a QC Team leader, your typical day may include:
•Performance management of a group of 10-15 QC Analysts, setting goals and objectives to challenge and develop the team members.
•Motivating and developing reports, providing technical expertise and leadership to help meet goals set in the performance management process.
•Supports the startup of the new lab areas, including equipment qualification, analytical method transfer, utility qualification and proves validation of the new manufacturing suite.
•Management of utility, raw material, in process and drug substance microbiology and QC testing activities.
•Provide technical support to manufacturing for QC issues in the plant; ensure QC support is available to support batch production process.
•Releases batches from QC according to site release timelines.
•Writing, reviewing and approving relevant QC procedures, deviations and change controls, and ensuring on time closure of records.
•Lead QC audit readiness team preparing for and participating in internal and external audits.
•Ensuring QC activities are completed in compliance with all relevant cGMP, regulatory, company quality and safety standards.
•Leading lean initiatives within QC, e.g. Visual Factory, GEMBA, KAIZEN and 5S
•Anticipating and planning for future requirements, initiating and driving cost and process improvement projects in the area.
•Lead the Values & Behaviors and Credo workshops for QC Department.
•Development and reporting on key performance indicators for the QC group.
•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
•Excellent social and communication skills
•Proven record of developing direct reports
•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)