Johnson & Johnson Careers
Analyst QC API (Separations)
Requisition ID: 1905737411W
Role: QC Analyst, Separations
Location: Ringaskiddy Cork, Ireland
Reports to: QC Team Leader - Separations
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.
We have an exciting opportunity for a QC Analyst in Separations on a permanent basis. This individual will be responsible for carrying out tasks and projects related to Separations analysis of biotechnology products as required by Good Manufacturing practice (GMP). The individual will participate in the delivery of lab testing efforts by using both existing and new procedures or processes to independently interpret data and identify and correct issues. Proposes ideas and next steps to supervisors and/or managers. Receives intermittent, moderately detailed instructions from Quality leaders at various levels, in addition to other stakeholders.
In this role, your typical day may include:
· Supporting the Separations Team Leader during day to day operations of area.
· Testing for laboratory related projects e.g. analytical method transfers, equipment qualification, invalid assay and NC reduction initiatives etc.
· Performing Separations analysis (e.g. HPLC, cIEF, cSDS).
· Identifying and implementing laboratory process improvements leading to improved efficiency &/or compliance within area.
· Authors and investigates internal investigations, participates in regulatory inspections & external technical discussions etc.
· Keeping up to date with analytical technology and regulatory / compliance trends.
· Participates in technical groups to implement laboratory activities while complying with local and global regulatory requirements as well as J&J standards.
· Supports the roll-out of laboratory activities (for example, instrument life-cycle management).
· Performs laboratory studies, projects, and processes/initiatives.
· Assists in developing lab strategies, policies, and guidelines linked to area of expertise (for example, creating Standard Operating Procedures).
· Contributes to external and/or internal manuscripts, regulatory reports, and technical reports.
· Supports equipment qualifications to ensure accuracy and consistency of results.
• Performing a wide variety of Separations testing to support raw material, in process, bulk and drug product release.
• Knowledge and experience of equipment qualification, analytical method transfers, root cause problem solving and continuous improvement desirable.
• A strong team player who is very customer focused, possesses excellent leadership and testing skills and both stakeholder and project management experience.
• Excellent collaboration & communication skills, both written and oral.
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
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.
To be part of this high performing team you will have:
• A BSc in Chemistry, Biochemistry or related Scientific discipline.
• 2+ years’ experience within a regulated biologics or pharma industry.
• Experienced in Separations related test methods e.g. HPLC, cIEF, cSDS.
• Technical troubleshooting and problem-solving skills.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or
• Be self-driven with excellent social, communication and stakeholder management skills.
• Acute attention to detail.
• A focus on patients and customers at all times.
• Prior experience of performing similar functions related to this role e.g. equipment & method qualifications, analytical method transfers, test investigations, testing etc.
Janssen R&D Ireland (7566)