Quality Control Analyst Role
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This role involves performing microbiological testing analysis on various samples, including finished drug product, in process materials, stability samples, and environmental monitoring. The successful candidate will be responsible for calibration and use of laboratory instrumentation, completing documentation associated with analytical results in a timely manner, and reporting any non-conformances to the QC Manager.
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Key Responsibilities:
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* Perform microbiological testing analysis on various samples, including finished drug product, in process materials, stability samples, and environmental monitoring.
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* Responsible for calibration and use of laboratory instrumentation.
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* Complete documentation associated with analytical results in a timely manner.
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* Report and document any non-conformances to the QC Manager.
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* Assist in preparation and review of area documentation, such as SOPs, reports, and protocols.
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* Assist in training of other analysts and ensure training compliance within assigned work area and QC.
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* Perform and assist in additional duties as directed by the QC Manager.
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* Ensure relevant assays are performed on samples in support of release test and stability test programs.
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* Support validation and qualification of test methods and processes.
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* Facilitate laboratory investigations and support associated product investigation.
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* Support laboratory inspection and audits.
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* Troubleshoot laboratory methods and instrument problems.
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* Establish and monitor trend analysis program.
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* Contribute to operations of Quality Control Laboratories.
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* Liaise with internal and external customers.
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* Record and review laboratory testing documentation to cGMP standard.
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* Implement and adhere to appropriate levels of cGMP within the laboratory.
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* Promote safety awareness and established culture of IIF within assigned work area.
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* Ensure sample analysis is conducted to meet batch disposition requirements.
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Requirements:
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The ideal candidate will have a third-level qualification in Science, Engineering, or equivalent. Excellent communication and interpersonal skills are essential for this role. Additional education may be considered where relevant skills and experience exist.
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