Website Integrated Resources, Inc
Integrated Resources, Inc
Company : Integrated Resources, Inc
Lab Technician II
Pay Range: $28-$31.58/hr.
Braintree, MA-on-site
Duration: 6 Months+
Potential temp to hire
ISO 13485 exp preferred, along with ISO 7 and 8 cleanroom
ISO 5 is even better
Must Have:
- Environmental Monitoring
- Water Monitor & Collecting
- Exp with Bioburden testing is great
- Microsoft Office experience – Advanced/Proficient
Responsibilities:
" 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 & Forms
" Responsible 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 assigned
Qualifications:
" 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.