QC Analyst - Microbiology

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.