Quality Control Core 2

Company: Cortech
Location: Rocklin
Posted on: June 22, 2022

Job Description:

PRIMARY OBJECTIVE OF POSITION:Under moderate supervision, the Stability Laboratory Assistant will be part of the Quality team and support stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements. This includes managing stability sample receipt, movement and staging, and reagent inventory, in addition to lab consumables, and equipment maintenance. The Stability Lab Assistant supports Stability Analysts who perform various scientific analyses for stability testing; and support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS.JOB RESPONSIBILITIES:Essential Duties and Responsibilities:---Managing stability sample receipt, movement through chambers and staging for testing---Management of reagent inventory and lab consumables.---Maintain lab equipment---Support Stability Analysts who perform various scientific analyses for stability testing---Perform data entry to record and document testing results accurately and per applicable regulatory and SOP requirements.---Data analysis using Microsoft Excel.---Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.---Maintain cGMP compliance in the laboratory.---Other duties as assigned or requiredAdditional Responsibilities:---Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management---Must be willing and able to work on weekends or extended hours as neededJOB CRITERIA:EDUCATION & EXPERIENCE:---Some college in a biological science or equivalent life sciences degree or equivalent experience is required---Experience in an FDA/ISO or other regulated environment is preferred---Experience with Quality Assurance/Quality Control is preferred---General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standardsKNOWLEDGE, SKILLS &ABILITIES:---Knowledge of cGMPs related to QC operations---Experience working in ISO 13485 and/or FDA regulated laboratory---Experience in SAP and/or SAP NEXT---Good computer skills, PC including MS Excel---Excellent written and verbal skills---Excellent organizational skills and attention to detail---Sound and accurate judgement and decision-making skills---Understands and adheres to the requirement of the Quality System

Keywords: Cortech, Rocklin , Quality Control Core 2, Other , Rocklin, California