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Lab Technician
Lab TechnicianSpectraforce Technologies • Waldorf, Maryland, United States
Lab Technician

Lab Technician

Spectraforce Technologies • Waldorf, Maryland, United States
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  • [job_card.full_time]
[job_card.job_description]

Job Title : cGMP Cleaner

Location : Frederick, MD 21704

Duration : 4+ Months (Possibility of Extension Depending Upon Business Requirements and Performance)

Hours : 5x8-Hour Days, 10 : 30 PM - 7 : 00 AM (Mandatory 1 Weekend Day a Week)

Training Hours : First Three Weeks, Monday-Friday, 7 : 30 AM-4 : 00 PM

Description

  • The Organization is a cell therapy company focused on providing patients with highly effective, life-saving therapies.
  • We have two commercial products, Yescarta and Tecartus, along with a robust pipeline of various autologous and allogeneic clinical programs.
  • We are seeking a highly motivated individual to join our Manufacturing organization as a cGMP Cleaner and support the startup of The Organization's brand-new, state-of-the-art commercial Cell Therapy facility in Frederick, Maryland.
  • The cGMP Cleaner, internally known as a Lab Tech II, will provide 3rd-shift cGMP cleaning requirements and sterile and non-sterile garment stocking for our ISO Class rooms and Controlled Non-Classified Lab Areas.

Responsibilities

  • Perform sanitary cleaning activities as defined by established operating procedures and as directed by Manager / Supervisor.
  • Perform sterile and non-sterile stocking, staging, and shifting (FIFO) of usable garments for multiple gowning rooms.
  • Maintain accurate and complete records.
  • Attend and complete all training required by Company SOPs, procedures, and policies.
  • Maintain accurate and complete inventory of cleaning supplies, ensuring supplies are never depleted.
  • Review and provide signatory signoff of documentation.
  • Provide accurate and complete assistance to other departments as needed.
  • Work in a safe and effective manner in accordance with all company, state, and federal rules and regulations.
  • Perform any other tasks / duties as assigned by management.
  • Embrace the QUALITY culture.
  • Basic Requirements

  • AA Degree OR High School Degree with 1+ Years of Operations and / or Pharmaceutical / Biotechnology and / or Manufacturing Experience.
  • Physical Environment and Physical Requirements

  • Physically capable to don and wear cleanroom / protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves (PPE are essential for the health and safety of employees).
  • Ability to wear a respirator during use of certain cleaning chemicals.
  • Perform operations within an ISO Class clean room.
  • Employee must be able to occasionally lift and / or move up to 40 pounds.
  • Must be able to squat, bend, kneel, and / or reach for 80% of a shift.
  • Must be able to stand, walk, and / or move about for 80% of a shift.
  • Preferred Qualifications

  • Clean Room sanitization experience or cGMP operational experience a plus.
  • Task Break Down (by %) : 75% Cleaning, 15% Documentation, 10% Other Duties as Assigned.
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