J&J Family of Companies Acting QC Specialist - Microbiology in Cork, Ireland
Location: Cork, Ireland
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 groundbreaking monoclonal antibody technology a ground breaking 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 now operational producing biomedicines for both the treatment of immune related diseases and new and creative cancer treatments.
This position is responsible for technically supporting QC Microbiological activities at JSI. Partners with other Departments to ensure that QC Microbiology Activities are completed in an efficient manner. Provides technical assistance to QC Analysts to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
Key Responsibilities :
Provides development and support of the QC Microbiology function through:
• Leading the qualification of the Microbiology laboratory in respect of microbial methods transferred from other GBSC sites.
• Leading the transfer of new or revised microbial methods from other GBSC sites and product development.
• Validation of microbial methods for use in QC labs.
• Training analysts from other labs in new or revised test methods.
• Reviewing and approving of relevant QC TM’s, SOP’s and WI’s.
• Promptly resolving QC equipment and QC method related issues by applying best practice trouble-shooting skills.
• Trouble shooting and support of manufacturing microbiological issues.
• Anticipating and planning for future requirements in the area.
• Ensuring QC activities are carried out in compliance with cGMP and company quality standards.
• Maintains records of investigation in accordance with cGMP.
• Participate in relevant internal and external QC related audits.
• Deputises for the QC Manager or Team Leader as appropriate.
Experiences and Skills:
• Excellent interpersonal skills.
• Ability to operate as part of a team is critical.
• Customer focus.
• Excellent communication skills both written and verbal.
• Attention to detail .
• Good problem solving skills.
• Results and performance driven.
• Adaptable and flexible.
• Strategic Thinker.
• Credo value of integrity.
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 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.
• BSc in a scientific/technical discipline required.
• A minimum of 5 years experience within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Janssen R&D Ireland (7566)