Job Description
A fantastic opportunity has arisen for a
QC Analyst.
Join a supportive, growing team in the analysis of Biologics and Vaccines in a state-of-the-art Quality Operations laboratory.
Carlow will manufacture and test the biggest selling biologic and the biggest selling vaccine product and is a strategic manufacturing site.
The
QC Analyst / Senior Technician Quality Control
will report directly to the QC Manager and will help us in the expansion of this Laboratory and complete analytical method transfers and validation as well as commercial testing.
The lab operates a 2 cycle and 4 cycle shift and roles are available in both.
Occasional travel may be required for training purposes.
Key Responsibilities
Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP.
Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
Participate in writing/revising/rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with the same.
Operate as part of the QC team performing the allocated testing and laboratory-based duties.
Perform various analytical techniques including but not limited to HPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements.
Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
Participate in the laboratory aspects of OOS investigations.
Provide support with audit/inspection requirements to ensure department compliance/readiness.
Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g., FMEA, Fishbone diagrams, 5 why's etc.
Work collaboratively to drive a safe and compliant culture on site.
Qualifications & Skills
In order to excel in this role, you will more than likely have:
Bachelor's Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
2-3 years' experience in a pharmaceutical laboratory, ideally with experience in HPLC and relevant systems and software.
Core to the role is to perform testing of samples to support the release of key drug products.
Good working knowledge of HPLC systems and software.
Good knowledge of cGMP, GLP, Quality Management Systems.
Additional Skills
Analytical Method Transfer
GMP Compliance
GMP Laboratory
Laboratory Analytical Techniques
Laboratory Information Management System (LIMS)
Laboratory Investigations
Laboratory Operations
OOS Investigations
Quality Control Management
Sterility Testing
Technical Procedures
The Carlow site broke ground in **** and is a filling site for the launch and commercial supply of vaccines, biologics, and small molecule drug product.
Since its initial launch, the site has attracted significant internal investment and is now home to a number of state-of-the-art production facilities, laboratories, and temperature-controlled warehousing units.
The Carlow site is a significant employer in the South East region and attracts high-performing talent through close collaborations with universities and colleges in the region.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
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