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.