Kindeva Drug Delivery Company
Quality Control Raw Materials Chemist
Kindeva Drug Delivery Company, Los Angeles, California, United States, 90079
19901 Nordhoff St, Northridge, CA 91324, USAJob Description
Posted Tuesday, March 19, 2024 at 4:00 AM | Expired Friday, March 22, 2024 at 3:59 AMKindeva is passionate about helping you realize the full potential of your career. We have the vision to see what’s possible, the expertise to make it happen and the agility to overcome any challenge along the way.Summary of PositionThe person hired for the position of Quality Control Raw Material Chemist will perform complex and routine analytical processes for the testing of Raw Materials and Hard Goods for pharmaceutical products. The Quality Control Raw Material Chemist will support issue resolution and communicate technical or other product quality issues. The Quality Control Raw Material Chemist will be responsible for leading safety initiatives and training, while driving completion of new product and continuous improvement projects. This opportunity will require appropriate techniques and tools such as, Six Sigma, LEAN, and SPC.Job ResponsibilitiesEnsure world-class safety within the quality control laboratory and Northridge Facility.Prepare sample solutions, standards, and reagents.Perform wet chemical and instrumental analysis, including FTIR, HPLC, UV Spectrophotometer, Gas Chromatography.Analyze Packaging Materials and Raw Materials per US Pharmacopeia (USP) Monographs/ National Formulary (USP-NF), European Pharmacopoeia (EP) and/or approved Test methods and Specifications.Meet multiple testing cycle time requirements through managing scheduling, testing and documentation review.Review and update lab documentation such as SOPs, worksheets, specifications and methods to reflect current processes.Perform or support qualification, calibration and maintenance of quality control laboratory equipment as needed.Support resolution of non-conformances such as Out of Specification and Out of Trend results through investigations in the Quality Control Laboratory.Ensure timely completion of CAPA and Action Items as assigned.Identify, plan and complete continuous improvement projects within the Quality Control Laboratory and Northridge facility.Support introduction of new analytical techniques and equipment to the Quality Control Laboratory.Ability to work flexible hours as needed to support production demands and rushes.Work well in both team and individual environments.Other duties as assigned.RequirementsBachelor’s degree or higher in a science discipline from an accredited university.Basic understanding of GMP/GLP.PreferredBachelor’s degree or higher in Chemistry from an accredited university.Testing experience within the pharmaceutical industry.Familiar with Raw Material testing, Global Compendia, and ICH.Demonstrated strong oral and written communication skills.Experience with LIMS, MasterControl, and various Office applications.Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.Equal Opportunity Employer:Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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Posted Tuesday, March 19, 2024 at 4:00 AM | Expired Friday, March 22, 2024 at 3:59 AMKindeva is passionate about helping you realize the full potential of your career. We have the vision to see what’s possible, the expertise to make it happen and the agility to overcome any challenge along the way.Summary of PositionThe person hired for the position of Quality Control Raw Material Chemist will perform complex and routine analytical processes for the testing of Raw Materials and Hard Goods for pharmaceutical products. The Quality Control Raw Material Chemist will support issue resolution and communicate technical or other product quality issues. The Quality Control Raw Material Chemist will be responsible for leading safety initiatives and training, while driving completion of new product and continuous improvement projects. This opportunity will require appropriate techniques and tools such as, Six Sigma, LEAN, and SPC.Job ResponsibilitiesEnsure world-class safety within the quality control laboratory and Northridge Facility.Prepare sample solutions, standards, and reagents.Perform wet chemical and instrumental analysis, including FTIR, HPLC, UV Spectrophotometer, Gas Chromatography.Analyze Packaging Materials and Raw Materials per US Pharmacopeia (USP) Monographs/ National Formulary (USP-NF), European Pharmacopoeia (EP) and/or approved Test methods and Specifications.Meet multiple testing cycle time requirements through managing scheduling, testing and documentation review.Review and update lab documentation such as SOPs, worksheets, specifications and methods to reflect current processes.Perform or support qualification, calibration and maintenance of quality control laboratory equipment as needed.Support resolution of non-conformances such as Out of Specification and Out of Trend results through investigations in the Quality Control Laboratory.Ensure timely completion of CAPA and Action Items as assigned.Identify, plan and complete continuous improvement projects within the Quality Control Laboratory and Northridge facility.Support introduction of new analytical techniques and equipment to the Quality Control Laboratory.Ability to work flexible hours as needed to support production demands and rushes.Work well in both team and individual environments.Other duties as assigned.RequirementsBachelor’s degree or higher in a science discipline from an accredited university.Basic understanding of GMP/GLP.PreferredBachelor’s degree or higher in Chemistry from an accredited university.Testing experience within the pharmaceutical industry.Familiar with Raw Material testing, Global Compendia, and ICH.Demonstrated strong oral and written communication skills.Experience with LIMS, MasterControl, and various Office applications.Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.Equal Opportunity Employer:Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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