Integra LifeSciences Holdings Corp.-posted about 2 months ago
$26 - $35/Yr
Full-time • Mid Level
Braintree, MA
1,001-5,000 employees
Miscellaneous Manufacturing

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Microbiology Technician II will be responsible for performing environmental monitoring, quality control microbiological laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and procedures purchased components, manufactured sub-assemblies and final product. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing.

  • Responsible for performing Microbiological testing such as Bioburden, Endotoxin, Gram staining, 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.
  • Training of new hires.
  • 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
  • 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.
  • Proficient computer competence, including experience with database and Microsoft Office Software to create reports, spreadsheets, analyze data and prepare presentations.
  • Working knowledge of standard laboratory practices and safety.
  • Ability to follow instructions precisely, recognize deviations, and recommend corrective action.
  • Experience with performing Microbiological assays in cGMP compliance lab and understanding of aseptic techniques.
  • Quality Certification (e.g., CQE, CQA, Six Sigma) preferred.
  • Experience working in ISO Class 7 & 8 clean-rooms preferred
  • medical
  • dental
  • vision
  • life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • savings plan (401(k))
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