QC Bioassay Technical Expert

QC Bioassay Technical Expert

Location: Cork

Duration: 12 months

Hours: 39 hours

The candidate must have a strong technical knowledge of analytical techniques and  strong knowledge of related laboratory equipment in one or more of the following areas:  Chemistry, Biochemistry, Bioassay or Microbiology. 

The individual will be responsible for: 

• Qualification of analytical equipment and related testing functions, for example  HPLC, Spectrophotometry, Nephelometry, Endotoxin, Cell Culture and Total  Organic Carbon etc. 

• Sampling and testing coordination during plant and laboratory utility qualification. 

• Co-ordinates & plans activities related to the successful transfer of Analytical  Methods for relevant NMEs. 

• Co-ordination of Raw material, Utilities, In Process, Final Bulk and Final product  analytical testing and sampling. 

• Support and Implementation of Analyst Training programs.  

Partners with other Departments and Team Leaders to ensure that activities related to  QC are completed in an efficient manner. 

Roles and Responsibilities

• Supports Team leader on day to day testing operations. 

• Performs Data and QC Investigations review and approval. 

• Reviews and approves deviations, CAPA’s and Change Control. • Plans and oversees lab related projects, ie., Method transfers, Equipment  Qualification etc., 

• Proactively identifies and drives lab process improvements. 

• Trains laboratory team on specific analytical technology. 

• Provides subject matter expert technical support on specific analytical  technology. 

• Supports lean initiatives in the area of lab operations, ie., test method execution,  documentation updates and equipment qualification etc.,

• Presents technical analytical clearly and concisely data to customers, internal  investigations and regulatory inspectors, etc., 

• Keeps abreast of analytical technology and compliance trends. 

How To Succeed

• Bachelor’s Degree in Chemistry ,Biochemistry, Micro or science related field. 

• 3-5 years related experience in biopharmaceutical or pharmaceutical industry.  And/or an equivalent combination of education and experience. 

• Working knowledge of regulatory requirements, policies and guidelines.  Experience with Quality Control document reviews and regulatory inspection  processes. 

• Working knowledge of Quality systems. 

• Strong technical knowledge in and experience with QC analytical testing  methods and equipment is required. 

• Knowledge of cGMP regulations and FDA/EU guidance is required. 

Benefits

This role offers a very competitive hourly rate. This contract will run for 12 Months.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

Application Process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.