QC Chemistry Analyst - mRNA

QC Chemistry Analyst - mRNA

Cpl in partnership with our client Pfizer are currently recruiting for QC Chemistry Analyst - mRNA:

Pfizer Grange Castle is one of the largest integrated biotechnology plants in the world and is a key part of the Pfizer global manufacturing network. It is an innovative, exciting, and growing organization that has a range of products and state of the art technologies.  

Job Purpose:  

To maintain regulatory compliance through established programs for laboratory testing, maintenance, training, and SOPs within Quality Control Chemistry. 

Job Responsibilities: 

·       Perform analysis on finished drug product, drug substance, in process materials and stability samples. 

·       Ensure that sample analysis is conducted to meet batch disposition requirements. 

·       Complete documentation associated with analytical results in a timely manner. 

·       Report and document any non-conformances to the QC Shift Lead. 

·       Assist in the preparation and review of area documentation e.g., SOP's, Reports, Protocols.  

·       Assist in the training of other analysts.  

·       Ensure training compliance within assigned work area and QC. 

·       Adhere to good laboratory practices and housekeeping standards. 

·       Perform and assist in additional duties as directed by the QC Shift Lead.  

·       Support any validation and qualification of test methods and processes.  

·       Facilitate laboratory investigations and support associated product investigations. 

·       Support Laboratory inspection and audits.

·       Troubleshoot laboratory methods and instrument problems.  

·       Establish and monitor trend analysis program.  

·       Contribute to the operations of the Quality Control Laboratories.  

·       Implement and adhere to appropriate levels of cGMP within the laboratory.  

·       Promote safety awareness and the established culture of IIF within the assigned work area. 

·       Participate and seek opportunities in the area of Right First Time principle and Continuous Improvement. 

Education/Experience: 

·      2+ years’ experience working in QC Laboratory.

·      Third level Qualification in Science, Engineering or equivalent is preferred though not essential. Exceptions may be considered where relevant skills/experience and correct attitude and behaviours exist (this may be supplemented by further education in parallel) 

·      Experience with Lab systems an advantage. (LIMS, CDAS, TrackWise, PDOCs) 

·      Experience in analytical techniques such as High-Performance Liquid Chromatography with Empower, Capillary Electrophoresis, Osmolality, Particulate Matter and UV testing is desirable.

·      Excellent communication and interpersonal skills.

·      This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.