QC Specialist

Janssen are now recruiting for a QC Specialist / QC Compliance Specialist based from Ringaskiddy Cork, Ireland reporting to the QC Manager. Description 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, particularly in groundbreaking monoclonal antibody technology, an 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 fully operational and currently expanding its operations to continue focusing on producing biomedicines for both the treatment of immune related diseases and new and creative cancer treatments. Job Purpose: We have an exciting opportunity for a QC Specialist. This individual will be responsible for overseeing Compliance related activities within the department including providing compliance related expertise during investigations including RCPS in addition to leading projects and initiatives aimed at driving down the cost of quality (CoQ) for our operations. This individual will also act as the primary lead for QC participation in all Regulatory and/or Internal Audits. In addition, this person will also be responsible for partnering and collaborating with other departments (e.g. QA, QS, BEX & other JSC laboratories ) to ensure that our operations and people are working to the highest level of quality and compliance. What you’re great at: Strong GMP background including a good understanding of Biopharmaceutical manufacturing processes & testing methodologies. Well versed in GMP Regulatory Audits including experience of one to one dialogue with Regulatory Inspectors. A strong team player who is very results oriented, possesses excellent leadership skills including both stakeholder and project management experience. Excellent collaboration, influencing and communication skills whilst also possessing excellent coaching skills and capability. Ability to interpret and analyze data to establish trends and conceptualize initiatives to counter these trends. Strong continuous improvement and lean methodology mindset. As an QC Specialist / QC Compliance Specialist , your typical day may include: Leading the QC QEM daily meeting involving the application of GMP Compliance and RCPS expertise. Applying advanced planning, co-ordination and execution skills required to ensure that all QEM related activities are completed within the necessary timelines and in line with site batch release requirements and other strategic commitments. Tracking and trending of Quality related data (e.g. invalid assays, investigations) including integration of this into daily performance management processes to identify improvement/reduction opportunities Proactively planning for, overseeing & participating in laboratory compliance & CoQ related projects e.g. NC Reduction Projects, DISC process sustainability, JJPS TIP’s etc. Maintaining oversight and involvement in QC EHS compliance activities, meetings, investigations and inspections. Consulting in lab-based investigations involving the use of problem solving and root cause analysis methodologies. Review and approval of quality investigations, CAPA’s & change controls, as required. Authoring of strategy documents, protocols and reports focused on improving the quality of operations and removal of complexity within our operations. Providing training, mentoring and guidance to the QC department on compliance related activities/content. Communicating with multiple stakeholders/departments both on and off site whilst acting as the SME relating to QC compliance. QC SPoC during internal investigations, regulatory inspections & external technical discussions etc. Keeping up to date with Data Integrity/ regulatory / compliance trends.
INDHP Qualifications To be part of this high performing team you will have: A BSc in Chemistry/Biochemistry/Microbiology, or other Scientific related discipline. 4+ years’ experience within a regulated biologics or pharma industry. Proven track record of project management and delivery. In-depth knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Experienced in process optimization, RCPS and other lean six sigma problem solving methodologies. Be self-driven with excellent interpersonal, communication and stakeholder management skills with a natural ability to coach and influence others. Acute attention to detail. A focus on patients and customers at all times. Preferred: First-hand experience of participating as an SME in Regulatory/Customer/Internal Audits. KPI management, data analytics and data visualization. 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 Primary Location Ireland-Cork-Cork- Organization Janssen R&D Ireland (7566) Job Function Quality Requisition ID 2105985635W