Kenny-Whelan (a specialist division of the CPL group) are hiring a QC Micro analyst for our Global Pharmaceutical client in Little Island , Cork
Contact Jenn Dinan on 0860466583 or email firstname.lastname@example.org
QC Micro Analyst –days position
This position is responsible for carrying out tasks and projects related to bulk solvent, utility, in process, release and sterility testing of pharmaceutical products as required by Good Manufacturing Practice (GMP).
GENERAL SCOPE OF RESPONSIBILITIES:
• Achieves a high level of competency in laboratory methods and procedures to support testing activities
• Performs routine and non-routine Microbiological 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 TMDs, SOPs and WIs as required.
• Writes and reviews Quality Issues and Investigations as required.
• 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
• Environmental Monitoring
• Growth Promotion
OTHER RESPONSIBILITIES / DETAILED DUTIES MAY APPLY:
• Maintains and develops knowledge of analytical technology as well as cGMP standards.
• Partners with other departments to ensure that all QC testing activities are completed in a compliant and efficient manner
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, Track wise and Electronic documentations systems.
• 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
• Ability to prioritise work based on strict sample hold times and customer needs
• Experience in utilising root cause problem solving tools
QUALIFICATIONS AND EXPERIENCE:
• BSc (Honors) in a scientific/technical discipline.
• A minimum of 1 year experience in a QC laboratory-testing environment within the pharmaceutical and/or biological industry.
• Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory
• Experience in aseptic technique
All application will be treated with the strictest of confidence.
Contact Jenn Dinan on 0860466583