Environmental Monitoring

3 weeks ago

Houston, United States Medix Full time

HIRING Environmental Monitoring Technicians Medix Life Sciences is the fastest growing staffing organization specializing in Clinical Research and Life Sciences placements for all the major health systems and research organizations throughout the country. Medix is looking for someone with 1+ years of clean room and/or aseptic experience.

Requirements:

  • High School Diploma/GED
  • 1+ years of clean room and or aseptic experience

Position Summary: Location: Houston, Texas 77054 Pay: 20-25/hr depending on experience Hours: 2nd shift 1pm-11:30pm M-TH Duration: 6 months contract to hire

Position Description:

  • Perform Environmental Monitoring (EM) in an aseptic environment (batch, routine, gowning monitoring and utilities testing).
  • Performs Daily, Weekly, Monthly and Quarterly EM.
  • Performs viable air, non-viable particle counts, and contact surface testing.
  • Completes all necessary documentation on GMP documents in real time.
  • Responsible for the accurate recording, review and storage of laboratory data.
  • Implement Data Integrity for reliable, accurate, and complete laboratory data.
  • Assist with the setup and daily running of the EM laboratory.
  • Participate in EM lab operations on a daily, weekly, monthly and quarterly schedule.
  • Incubate and enumerate organisms on cultured media.
  • Prepare for shipping to a contract lab, Out-of-Specification (OOS) media plates and finished product.
  • Ship QC equipment for calibration as required per established policies and procedures.
  • Provide EM support including review, tracking of EM of Microbiology results in
  • support of product release.
  • In conjunction with Quality Assurance, ensure timely completion and data review of routine and batch-related microbiological data.
  • Assist with facility qualification and validation as required.
  • Ensure proper equipment function, calibration, maintenance and troubleshooting of
  • laboratory equipment.
  • Assist with the initiation of investigations/deviations and the determination of root causes analysis.
  • Participate in hazardous waste training. Transfer of hazardous waste between lab and trash accumulation area/storage.
  • Seeks continuous improvement within EM related activities.
  • Initiates the review/revision of EM related Standard Operating Procedures (SOPs).
  • Supports the QC Manager in projects relating to EM technician tasks.
  • Follow best practices, quality trends and regulatory requirements.
  • Follows Standard Operating Procedures designed to ensure quality in EM tasks, consistent with established standards in Wells Pharma.
  • Ensures compliance with the US Food, Drug & Cosmetic Act.
  • Perform additional duties as required and assigned by the Quality Control Manager, such as but not limited to the following:
  • Receive and inspect incoming shipments of GMP materials and equipment following
  • established procedures and Certificate of Analysis.
  • Prepare and sign-out raw materials, samples, finished product, etc. to Manufacturing and Quality, ensuring proper procedure and temperature range are followed.
  • Ensure QC department supplies are inventoried and ordered to avoid stock-out.
  • Maintains control of all Sample Retain containers from receipt to disposal.
  • Participates in the receiving of Sample Retains from operations.
  • Organize and submit in-process and final-release Sample Retains for shipping to a contract lab for testing.
  • Liaise between Operations and QC as pertains to Sample Retains.
  • Organize and maintain Sample Retain logs on Microsoft Excel
  • Maintain the Sample Retain inventory room, refrigerators, and freezers.
  • Record the daily storage temperatures of incubators, refrigerators, and freezers.
  • Ensure that Sample Retains are stored in appropriate locations.
  • Ensures adequate storage areas are available in each sample storage area.
  • Ensure Sample Retains are readily available for Shipping with proper documentation.
  • Prepare for shipping testing to contract labs for chemistry and microbiology samples.
  • Dispose of Sample Retains in accordance with cGMP regulations after retention time has passed.
  • Organize Sample Retains by lot/batch number, documenting the storage location in
  • logbooks/excel for ease of retrieval.

Qualified candidates are encouraged to apply We would love to discuss these positions with you further

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