Quality Assurance Expert job in Rocklin, CA
Vacancy has expired
Rocklin, CA CorTech LLC
| Job Ref: | 361687 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 30.00/Per Hour |
| Remote: | No |
Location |
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| City: | Rocklin, CA |
| Post Code: | 95677 |
| Map: |
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Description |
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JobsRUs.com. is seeking t hire a Quality Assurance Expert in for our client in Rocklin CA! Benefits Available! Weekly Pay! $30.00/Hour DESCRIPTION: Results-driven Quality Specialist with over 3 years of experience in the biotechnology industry with assurance methodologies and regulatory compliance and a proven track record of enhancing product and service quality through meticulous analysis, process improvement, and team collaboration. Responsible for Process Development, Manufacturing, Regulatory Affairs, and Project Management teams to ensure Clinical Studies were tested in accordance with established procedures, cGMP, and relevant regulations. Experience performing the QA document control function within QA that includes managing document workflows in Zen, tracking, processing, approval, distributing and archiving documents/records with overall responsibility for document control processes. Experience working with technical teams to develop several molecular assays which combined experimental design, reagent preparation, assay set-up, and data analysis. EDUCATION: Bachelor of Science in Biology Jun 2019 University of California, Riverside SKILLS: Smart sheet JIRA Manufacturing Project Planning Risk Management ISO Standards 21 CFR 820 CAPA Documentation cGMP GDP QA QC IVDD Internal & external audits PROFESSIONAL EXPERIENCE: Precision for Medicine ? Redwood City, CA Jan 2023 ? Present Quality Assurance Specialist II Coordinates and manages projects for assigned life science initiatives, driving cross-functional teams to achieve successful outcomes. Collaborates with key stakeholders such as Process Development, Manufacturing, Regulatory Affairs, and Project Management teams to ensure Clinical Studies were tested in accordance with established procedures, cGMP, and relevant regulations. Identifies anticipated issues, risks, and solutions, taking a proactive approach in coordinating and executing timely resolutions. Acts as the go-to authority on the complaint investigation process, serving as the Subject Matter Expert (SME) for both internal and external audits. Leads and coordinates investigations, to resolve quality- related issues by providing recommendations for corrective and preventative actions (CAPAs), nonconformance, and deviations. Supports the continuous improvement of operations between clinical and non-clinical staff through the development, evaluation, and refinement of policies and procedures that meet the operational and regulatory goals and requirements. Performs the QA document control function within QA that includes managing document workflows in Zen, tracking, processing, approval, distributing and archiving documents/records with overall responsibility for document control processes. Demonstrates self-direction and initiative, effectively managing routine work with minimal instruction, while seeking guidance for new assignments. Lucira Health ? Emeryville, CA Sep 2021 ? Nov 2022 Process Development Associate Engineer Authored and executed test plans, validation protocols, process qualification plans and reports. Lead scale-up of new resins from lab to manufacturing guiding process and analytical development. Standardized, simplified, rationalized, and organized project reporting to improve execution. Managed a forecast with the Supply Chain and Quality Control teams to keep track of the primer mix, pellet, and buffer manufacturing processes to ensure there was an adequate amount of inventory prior to scaling up for upcoming product launches. Identified and developed new processes and product opportunities that created distinct value and improved business processes by 15%. Research Associate Worked closely with Lead Product Development Scientist in the verification and validation of the sub-system of Lurtcira Health COVID-19 All-in-One Test Kit, as well as the upcoming Flu/Covid Device. Effectively managed activities associated with multiple concurrent and complex projects to deliver results in a timely manner, by developing and maintaining cross-functional project plans. Created excel sheets and standardized operating templates to effectively track product inventory leading to an increase in productivity of lab operation processes. Worked with technical teams to develop several molecular assays which combined experimental design, reagent preparation, assay set-up, and data analysis. Presented results to scientific team. Led weekly Assay Manufacturing meeting, highlighting manufacturing needs for upcoming projects, including lab space coordination and inventory check for both site locations. | |
ref: (361687)
431 days ago
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