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Microbiologist
Location:
US-MA-Boston
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Hello,
This is Subhash from (link removed)C, please find the below opening with one of our clients in the USA and try to share your format resume to subhash@intellectt.com or call 732 696 7097.

Role: Microbiologist
Location: Boston, MA

RESPONSIBILITIES:

  • Generation and execution of microbial method validation protocols and reports including the writing, routing and approval of summary documentation.
  • Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting.
  • Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11135, CMDR, Medical Device Directive, and USP.
  • Interpret microbiological data in order to identify trends and issues that require investigation.
  • Contribute to risk management activities including PFMEA generation.
  • Scheduling coordination, material allocation and alignment of personnel in order to successfully complete project assignments.
  • Create procedures for microbiological testing and sampling in alignment with validations and in compliance with applicable regulations.
  • Serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects as necessary including supervision of contract resources.
  • Experience with Controlled environment monitoring, Water system monitoring, compressed air monitoring, Bacterial endotoxin test method validation, and monitoring, Bio burden test method validation and monitoring, and ethylene oxide sterilization preferred.
  • Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
  • Support and address comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures.
  • Change control, non-conformance, and CAPA support.
  • Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.

DESIRED MINIMUM QUALIFICATIONS:

  • Bachelors, or preferably Master of Science degree, in Microbiology or a similar discipline.
  • 4-7 years of experience in a Microbiology focused role for a medical device or pharmaceutical environment.
  • Demonstrates excellent organizational and communication skills.
  • Excellent technical writing skills with an understanding of good documentation practice.
  • Experience conducting microbial test method validations and managing projects independently.
  • Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.
  • Working knowledge of applicable microbiology standards including, but not limited to, AAMI ST72, ISO 11737, ISO 14644, ISO 11135, and USP.
  • Working knowledge of applicable regulations and their interpretation within the industry.

Intellectt INC

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