Job Description

Quality Control Chemistry Analyst (Bioprocessing)

Dublin- Grange Castle

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:

• 3-4 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 behaviors 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 Electrophoresis

• ICP-OES

• UV Spectroscopy

• SDS-PAGE

• Karl Fisher

• 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