QC Analyst

1 month ago

Ireland CPL Healthcare Full time

QC Microbiology Analyst

Cpl in partnership with our client Pfizer are currently recruiting for Quality Control Analysts to join their Microbiology team.

Job Purpose:

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

Job Responsibilities:

·Perform Microbiological testing analysis on, but not limited to, finished drug product, in process materials, stability samples and environmental monitoring.

·Responsible for calibration and use of laboratory instrumentation.

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

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

·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.

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

·Ensure relevant assays are performed on samples in support of release test and stability test programs.

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

·Facilitate laboratory investigations and support associated product investigation.

·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.

·Liaise with all customers both internal and external.

·Record and review laboratory testing documentation to cGMP standard.

·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.

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

Education/Experience:

To be successful in this role the following are prerequisites to application:

·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)

·Minimum 1 years’ experience in a GMP microbiology lab.

·Excellent communication and interpersonal skills.

·Experience in endotoxin and bioburden testing an advantage.

People / Values:

·Demonstrate the GC OWNIT values.

·Adhere to all HR Policies as appropriate.

·Proactive engagement with key stakeholders.

·Best practices developed and shared with other teams /sites.

·Best practices actively sought and copied.

·Proactive & effective communication within and across shifts.

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