Separation QC Analyst - CORK

SEPARATION QC ANALYST
 

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.
 

The Project:

This position is responsible for carrying out tasks and projects related to testing procedures, equipment and lab utilities as required by Good Manufacturing Practice (GMP).

Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner. 

The Role:

• 12 Month Contract 
• € 18-22
• Based in Cork

Duties and Responsibilities:

• Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products.
• Review and approval of laboratory test results. 
• Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines. 
• Executes validation, operation, maintenance, calibration and troubleshooting of equipment and it’s associated software. 
• Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use. 
• Ensures that all testing is completed, reviewed and approved within agreed turnaround times.
• Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.
• Trains other QC analysts in laboratory methods and procedures when required.
• Writes/updates and reviews TMs, SOPs and WIs as required.
• Writes and reviews invalid assays, non-conformances and deviations as required.
• Actively participates in JSI lean initiatives such as Kaizen, 6S and Gemba. 
• Is an active member of the QC group and provide assistance with other group activities as required.
• Communicates relevant issues to the QC Team Leader promptly.
• Maintains and develops knowledge of analytical technology as well as cGMP standards. 

SPECIFIC TESTING EXPERIENCE REQUIRED

• HPLC
• Capillary Electrophoresis
• UPLC/Mass Spec (desirable)

KEY COMPETENCIES REQUIRED:

• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Excellent communication skills both written and verbal.
• Good knowledge of LIMS, Trackwise and Electronic documentation systems.
• Good knowledge of Microsoft Office applications such as word, Excel, PowerPoint
• Experience working in a high throughput laboratory environment.
• Excellent technical writing skills.
• Customer focus.
• Attention to detail.
• Strong problem solving skills.
• Results and performance driven.
• Adaptable and flexible.

QUALIFICATIONS AND EXPERIENCE: 

• BSc (Honors) in a scientific/technical discipline. 
• A minimum of 2 years’ experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory

In Return:

In return for this role you will receive a very competitive hourly rate. A minimum 12 month contract & an opportunity to work with a Global Leader within the Pharmaceutical sector, Johnson & Johnson. 

Things to remember before applying for this role:

• This role is Inside IR35. The pay rate for this role will depend on how you are paid (PAYE or Umbrella options).
• We are looking to process the first round of applications within the next 2 working days.
• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application. 
 

If you would like some additional information about the role please contact: 

Courtney.wells@randstadsourceright.co.uk 

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”.