Lab Technician II - DD2025

Work Type: 100% fully onsite Description:ISO 13485 exp preferred, along with ISO 7 and 8 cleanroomISO 5 is even betterMust Have:Environmental MonitoringWater Monitor & CollectingMicrosoft Office experience - Advanced/ProficientExp with Bioburden testing is greatResponsibilities:Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Growth promotion testing, TOC & Conductivity testing, sending samples for Microbial ID testing and other micro testing.Perform Environmental monitoring of clean rooms including Viables and Non-viables testing and responsible of water samples collection and testing.Working knowledge of aseptic techniques and provides database support, generates reports, and analyzes the data as needed.Inspection and testing of raw materials, in-process, and final product testing.Assist in trending environmental monitoring data. Report and investigate any monitoring excursions.Monitors equipment and instrumentation used daily to ensure proper operation and calibration.Maintains a working inventory of all components, materials and solutions as needed.Develops and revises SOPs & FormsResponsible for identifying and alerting supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions.Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs).Assists in the writing and updating of Microbiological test procedures, protocol, logbooks, and checklists.Assist as needed in test method validation, investigation studies or other product development studies.Assist in preparing for and participating in FDA audits, customer audits, etc.All other duties as assignedQualifications:Bachelor’s degree in Microbiology, Biology, or a relevant scientific discipline.A minimum of 2-4 years’ experience in a medical device, pharmaceuticals, Quality/Regulatory Compliance, or other cGMP regulated product preferred environment.Familiarity with application of FDA and/or ISO quality standards in a government regulated industry. Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.Proficient computer competence, including experience with database and Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations.Experience with performing Microbiological assays in cGMP compliance lab and understanding of aseptic techniques.Working knowledge of standard laboratory practices and safety.Ability to follow instructions precisely, recognize deviations, and recommend corrective action.Experience working in ISO Class 7 & 8 cleanrooms preferred.Company DescriptionTechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. We also have national recruiting

Salary : $32