Aequor Information Technologies Pvt. Ltd. · 5 hours ago
Senior Quality Control Associate
Fremont, CA
Contract
Onsite
Senior LevelAequor Information Technologies Pvt. Ltd. is seeking a Senior Quality Control Associate to oversee various QC functional areas. The role involves executing and coordinating analytical testing of bulk drug substances and drug products in a multi-product facility, ensuring compliance with regulatory standards, and training other associates.
ConsultingDigital MarketingInformation Technology
Hiring Manager
Prince Kumar
Responsibilities
Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing
Executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility
Execute and coordinate Raw Material sampling and testing and sampling of clean rooms (as applicable)
Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed
Coordinates and maintains routine activities
Responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs)
Performs duties under limited supervision and according to standard operating and QC procedures
Trains other associates and technicians on methods and processes
Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment
Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance
Required to work according to given schedules and flexibility to adapt working schedule upon prior given notice
Strong focus on execution of non-routine analytical methods or processes
Performs testing and review within several different analytical technologies
Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
Reviews and trends analytical data and compliance processes to identify out of trends
Authors routine compliance documents
Identifies process anomalies and areas for improvement for operations
Qualification
Required
Employee assigned to QC functional or technical area in either HPLC/CE, Potency testing (Bioassay and Binding assays), Residual Impurities, Physicochemical/Drug Product, Microbiology/Environmental monitoring, Raw Materials/Cleaning validation/verification and Packaging testing
Executes and coordinates analytical testing of bulk drug substance and drug product in a multi-product facility
Execute and coordinate Raw Material sampling and testing and sampling of clean rooms (as applicable)
Proficiency in 3-5 analytical methodologies within different scientific principles, including technical review, interpretation and trending as needed
Coordinates and maintains routine activities
Responsible for routine quality and compliance activities (authoring of test methods, specs, plans, reports, forms, SOPs)
Performs duties under limited supervision and according to standard operating and QC procedures
Trains other associates and technicians on methods and processes
Work performed in a highly regulated (FDA, EMEA, MHRA, PMDA etc.) environment
Follow all applicable BI and BI Fremont SOPs, OCPs and BGSs for cGMP, EHS and Compliance
Required to work according to given schedules and flexibility to adapt working schedule upon prior given notice
Strong focus on execution of non-routine analytical methods or processes
Performs testing and review within several different analytical technologies
Strong understanding of analytical chemistry and/or analytical testing as it applies to biopharmaceuticals
Reviews and trends analytical data and compliance processes to identify out of trends
Authors routine compliance documents
Identifies process anomalies and areas for improvement for operations
Manufacturing Cell Culture, Manufacturing Purification, Engineering & Technology, Quality Assurance, Quality Control, Quality Systems, Analytical Science
Company
Aequor Information Technologies Pvt. Ltd.
Aequor information technologies (P) limited is a part of US based IT MNC having more than 10 locations around the world with $ 100 M turnover.
Founded in 1998
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase