Purpose: Quality Control (QC) Analyst is responsible for sample receipt, testing intermediate production samples, final product samples, and environmental samples to demonstrate that all products meet the standard requirements for CGMP operations.
Additional functions include raw material testing, stability testing, assay transfers, and qualification of instrumentation.
The Quality Control Operations group supports Laboratory Investigations, Deviation Investigations, CAPA support, Training, and Change Controls.
Quality Control Validation Support consists of the Method Validation Group and the Equipment Qualification Group.
Quality Control is also responsible for assisting in site wide studies and projects.
Responsibilities Executing analytical testing in a timely manner, ensuring adherence to the committed scheduled plans Performing tasks in accordance with c GMP and HSE requirements, and with the associated instructions, procedures, records, related to these tasks Recording all expected raw data, calculations, information, related to tasks, to comply with c GMP and data integrity requirements Ensuring that he/she is trained and qualified to the assigned analytical testing that requires qualification Performing the QC data review of executed tests by other analysts in a timely manner, ensuring adherence to the committed scheduled plans Informing his/her manager of any quality or HSE event (deviations, OOx,…) in a timely manner to ensure investigation and impact assessment are performed appropriately Participating actively in any investigation in which he/she is involved, to ensure investigations and impact assessment are performed appropriately Executing assigned CAPAs related to remediation plans, continuous improvements Ensuring that his/her lab/facilities, lab instruments are kept in a quality and safe status so that they can be used appropriately Qualifications Bachelor's degree in pharmacy, chemistry, biochemistry, microbiology, life sciences, or a related field3+ years of experience in a quality control laboratory environment Experience in analytical testing of raw materials, intermediate and final products, and environmental samples Experience with stability testing, assay transfers, and instrument qualification Proficient in performing tests according to c GMP and HSE standards Skilled in recording and reviewing raw data accurately, ensuring data integrity Experience in laboratory investigations, deviation investigations, CAPA execution, change controls, and training support Familiarity with method validation, equipment qualification, and site-wide quality improvement projects Strong attention to detail and adherence to schedules Analytical and problem-solving skills with the ability to work collaboratively in a team Ability to maintain laboratory safety, quality, and compliance standards
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