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.