Quality Control Analyst

Job description

Janssen Biologics 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 now operational producing biomedicines for both the treatment of immune related diseases and new and innovative cancer treatments.

We have an exciting opportunity for a Quality Control (QC) Analyst to join our Quality Control team on a permanent basis. The QC Analyst is responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures at JSI as required by GMP. The QC Analyst will also work closely with other departments to ensure all QC testing activities are completed efficiently and smoothly.

What you're great at:

· Strong problem solving skills

· Excellent communication, written and oral

· Acute attention to detail

· Excellent team player with strong customer focus

· Knowledgeable of FDA/HPRA/EMEA regulatory requirements

As a QC Analyst, your typical day may include:

· Achieves competency in JSI laboratory methods and procedures.

· Trains other QC analysts in laboratory methods and procedures when required.

· Performs analytical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR USP and EP guidelines.

· Performs routine and non-routine analytical testing activities.

· Review and approval (where appropriate) of laboratory test results.

· Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.

· Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader and Manager.

· Anticipates and plans for future requirements in the area.

· Deals with non-conformances/ deviations in an accurate and timely manner.

· Deputizes for the QC Team Leader as appropriate.

What you'll own and how you'll grow:

Within this role, you will gain opportunities to facilitate an environment of continuous improvement whilst working strategically with other departments.

Desired profile

BE VITAL:

To be part of this high performing team you will have great attention to detail, alongside

·  A third level qualification in a scientific/ technical discipline.
·  Experience of working within a laboratory testing environment within the Biological/ Pharma Industry.
·  Knowledgeable of FDA/HPRA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
·  Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.
·  Excellent communication skills, both written and Oral
·  Excellent attention to detail with strong problem solving skills.
·  Proven drive towards results and performance