Kindeva Drug Delivery Company
Quality Control Chemist
Kindeva Drug Delivery Company, Los Angeles, California, United States, 90079
Job Description
Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturer (CDMO) business headquartered in Woodbury, MN with locations in California, Minnesota, and the United Kingdom. Kindeva partners with global pharmaceutical companies to commercialize products, with a particular focus on complex drugs and combination products. We are looking for a laboratory assistant to join our team.Summary of PositionThe person hired for the position of Quality Control Chemist will perform complex and routine analytical processes for the testing of Raw Materials, Hard Goods, and Finished pharmaceutical products. The Quality Control Chemist will support issue resolution and communicate technical or other product quality issues. The QC Chemist is 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, while demonstrating leadership in audits.Job Responsibilities
Ensure world-class safety within the quality control laboratory and Northridge Facility.Prepare sample solutions, standards, and reagentsPerform wet chemical and instrumental analysis, including FTIR, HPLC, UV Spectrophotometer, Dissolution, Instron, Texture Analyzer, and Gas ChromatographyAnalyze Packaging Materials, Raw Materials, and Finished Products per USP/NF/EP Compendia and approved Test methods and SpecificationsMeet multiple testing cycle time requirements through scheduling, testing, and documentation reviewReview and update lab documentation such as SOPs, worksheets, specifications, and methods to reflect current processes, etc.Perform, support qualification, calibration, and maintenance of quality control laboratory equipmentSupport resolution of non-conformances and investigations in the quality control laboratoryEnsure timely completion of CAPAIdentify, plan, and complete continuous improvement projects within the laboratory and Northridge facilitySupport the introduction of new analytical techniques and equipment to the quality control laboratoryAbility to work flexible hours as needed to support production demandsWork well in both team and individual environmentsOther duties as assignedRequirements
Bachelor's degree or higher in a science discipline from an accredited universityBasic understanding of GMP/GLPMinimum 1+ years analytical testing experiencePreferred
Bachelor's degree or higher in Chemistry from an accredited universityTesting experience within the pharmaceutical industryFamiliar with Raw Material testing, Global compendia, and ICHFamiliar with Inhalation or Transdermal products and test methodsExperienced in leading technical lab investigationsDemonstrated strong oral and written communication skillsDemonstrated ability to lead technical teamsMust be legally authorized to work in the country of employment without sponsorship for employment visa status.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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Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturer (CDMO) business headquartered in Woodbury, MN with locations in California, Minnesota, and the United Kingdom. Kindeva partners with global pharmaceutical companies to commercialize products, with a particular focus on complex drugs and combination products. We are looking for a laboratory assistant to join our team.Summary of PositionThe person hired for the position of Quality Control Chemist will perform complex and routine analytical processes for the testing of Raw Materials, Hard Goods, and Finished pharmaceutical products. The Quality Control Chemist will support issue resolution and communicate technical or other product quality issues. The QC Chemist is 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, while demonstrating leadership in audits.Job Responsibilities
Ensure world-class safety within the quality control laboratory and Northridge Facility.Prepare sample solutions, standards, and reagentsPerform wet chemical and instrumental analysis, including FTIR, HPLC, UV Spectrophotometer, Dissolution, Instron, Texture Analyzer, and Gas ChromatographyAnalyze Packaging Materials, Raw Materials, and Finished Products per USP/NF/EP Compendia and approved Test methods and SpecificationsMeet multiple testing cycle time requirements through scheduling, testing, and documentation reviewReview and update lab documentation such as SOPs, worksheets, specifications, and methods to reflect current processes, etc.Perform, support qualification, calibration, and maintenance of quality control laboratory equipmentSupport resolution of non-conformances and investigations in the quality control laboratoryEnsure timely completion of CAPAIdentify, plan, and complete continuous improvement projects within the laboratory and Northridge facilitySupport the introduction of new analytical techniques and equipment to the quality control laboratoryAbility to work flexible hours as needed to support production demandsWork well in both team and individual environmentsOther duties as assignedRequirements
Bachelor's degree or higher in a science discipline from an accredited universityBasic understanding of GMP/GLPMinimum 1+ years analytical testing experiencePreferred
Bachelor's degree or higher in Chemistry from an accredited universityTesting experience within the pharmaceutical industryFamiliar with Raw Material testing, Global compendia, and ICHFamiliar with Inhalation or Transdermal products and test methodsExperienced in leading technical lab investigationsDemonstrated strong oral and written communication skillsDemonstrated ability to lead technical teamsMust be legally authorized to work in the country of employment without sponsorship for employment visa status.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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