RenaudExec & Associates Inc.
Analyst, Quality Control
RenaudExec & Associates Inc., Los Angeles, California, United States,
Our client, a Canadian pharmaceutical company with fully integrated infrastructures for R&D, manufacturing, distribution, and marketing, is looking for a Quality Control Analyst for their laboratory. Their vast product line includes innovative and generic products as well as over-the-counter products, which are exported to several countries around the world.The position relies heavily on comprehensive wet chemistry techniques, dissolution, HPLC, and UV testing on raw materials, in-process, final products, and stability samples per established SOPs and pharmacopoeia product specifications.As a QC Analyst, you will be:
Performing tests for Certification of Analysis of Raw Material, Finished Products, and Stability SamplesDocumenting and reporting results in accordance with GMP and GLPParticipating in method validation protocols and reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, product specifications, and regulatory guidelinesParticipating in method development and method validation/verification for API and finished productsAssisting in the resolution of issues with respect to laboratory analysis and laboratory instrumentationPerforming all work in accordance with established regulatory, compliance, and safety requirementsConducting investigations of unexpected issues in developmental and regular products as directed and providing solutions to resolve the findingsRevising and updating existing methods when requiredParticipating in the development and/or providing recommendations for department SOPs and proceduresEducation and Competencies:
Education: Master or Bachelor in Science, major in ChemistryExperience: Minimum of 3 years Quality Control experience in the Pharmaceutical industrySpecialized Training: Good knowledge and understanding of GMP, GLP, analytical techniques, and method validationSound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.Sound understanding of current GMP, ICH, and FDA requirementsExcellent organizational skills to meet frequent changes in immediate priorities, problem-solving skills, and understanding of various computer software programs requiredExcellent oral and written communication skills in English and FrenchWilling to work in a team-based environment
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Performing tests for Certification of Analysis of Raw Material, Finished Products, and Stability SamplesDocumenting and reporting results in accordance with GMP and GLPParticipating in method validation protocols and reports in a timely manner with accuracy and precision in compliance with laboratory SOPs, product specifications, and regulatory guidelinesParticipating in method development and method validation/verification for API and finished productsAssisting in the resolution of issues with respect to laboratory analysis and laboratory instrumentationPerforming all work in accordance with established regulatory, compliance, and safety requirementsConducting investigations of unexpected issues in developmental and regular products as directed and providing solutions to resolve the findingsRevising and updating existing methods when requiredParticipating in the development and/or providing recommendations for department SOPs and proceduresEducation and Competencies:
Education: Master or Bachelor in Science, major in ChemistryExperience: Minimum of 3 years Quality Control experience in the Pharmaceutical industrySpecialized Training: Good knowledge and understanding of GMP, GLP, analytical techniques, and method validationSound theoretical and technical knowledge of chromatographic sciences and spectroscopic technologies such as UV, IR, GC, HPLC, LC-MS, AA, TOC, etc.Sound understanding of current GMP, ICH, and FDA requirementsExcellent organizational skills to meet frequent changes in immediate priorities, problem-solving skills, and understanding of various computer software programs requiredExcellent oral and written communication skills in English and FrenchWilling to work in a team-based environment
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