QC Analyst

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a QC Micro Analyst to join our contingent workforce on a growing team in Janssen Pharmaceuticals in Cork. This will be an initial 12 month contract.

About Janssen Pharmaceuticals:

Janssen Pharmaceuticals Sciences UC has also been operating in Cork since 1981. Janssen Pharmaceuticals Sciences UC is manufacturing bulk active pharmaceutical ingredients in Little Island that are sold throughout the world to other Janssen and third party companies where they are further processed into tablets, creams or injectable dosage forms.

The Role: 

This position is responsible for carrying out tasks and projects related to raw material, utility, in process, release and stability testing of biotechnology products as required by Good Manufacturing Practice (GMP).

Key Responsibilities:

• Achieves a high level of competency in laboratory methods and procedures to support raw material, utility, in process, release and stability testing of biotechnology products.
• Performs routine and non-routine Microbiological and or Biochemical/Chemical testing activities as required.
• 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 and Manufacturing personnel 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.
• Initiates and drives change controls to completion to implement process improvements.
• Actively participates in JBIL lean initiatives such as Kaizen, 5S 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.

Specific Testing Experience Required

• Initiation and Maintenance of Mammalian Cell Lines
• Cell Culture Based Bioactivity Testing
• ELIZA Testing
• qPCR Testing
• Bioburden
• Endotoxin
• Environmental Monitoring
• Microbial Identification

Candidate Requirements:

• 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
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Excellent communication skills both written and verbal
• Good knowledge of LIMS, Track wise and Electronic documentations 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
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible

If you meet our requirements and are interested in hearing more about our QC Micro Analyst role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!