QC Chemistry Biosimilars Analyst
Cpl in partnership with our client Pfizer are currently recruiting for QC Chemistry Analyst - Biosimilars:
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 Team 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 investigation.
• Support Laboratory inspections 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 and continuous improvement.
Education/Experience:
• 2+ years’ experience working in QC Laboratory desired
• 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
• Empower
• TrackWise
• PDOCs
• Industry Experience in some or all of the following analytical techniques is desirable:
• High Performance Liquid Chromatography (HPLC) with Empower
• Capillary Gel Electrophoresis (CGE)
• Imaged Capillary Electrophoresis (iCE)
• UV Spectroscopy
• Karl Fisher titration
• Particulate Matter
• 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.