Lab Technician-II(CGMP Cleaning)

NexInfo Solutions, Inc.; Frederick (MD); Sur place; USD 25 000 - 39 000; Plein temps

Résumé du poste

NexInfo Solutions, Inc. is seeking a highly motivated individual for the role of cGMP Cleaner (Lab Tech II) in Frederick, Maryland. The position supports a commercial cell therapy facility, performing 3rd shift cleaning duties and gowning material stocking for ISO Class rooms and controlled lab areas.

The role emphasizes adherence to quality culture, strict PPE usage, and accurate documentation. Requires basic science or manufacturing background with readiness to train and work in a regulated,

Qualifications

• AA degree or high school degree with 1+ years of operations/pharma/biotech/manufacturing experience.
• Ability to don PPE and work in cleanroom environments.
• Experience with record-keeping and documentation.
• Familiarity with cGMP standards and ISO-classified areas.

Responsabilités

• Performs sanitary cleaning according to SOPs and supervisor directions.
• Stocking and staging sterile and non-sterile garments for gowning rooms.
• Maintains accurate records and completes training as required.
• Reviews and signs off on documentation and assists other departments as needed.
• Works safely, complying with all company, state and federal regulations.

Connaissances

cGMP

Sterile technique

Documentation

Quality processes

Formation

AA Degree

High School Degree with 1+ years experience

Description du poste

We are seeking a highly motivated individual to join our Manufacturing organization as an cGMP Cleaner and 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

• Performs sanitary cleaning activities as defined by established operating procedures and as directed by Manager/Supervisor
• Performs sterile and non-sterile stocking, staging and shifting (FIFO) of usable garments for multiple gowning rooms
• Maintains accurate and complete records
• Attends and completes all training required by Company SOPs, procedures and policies
• Maintains accurate and complete inventory of cleaning supplies ensuring supplies are never depleted
• Reviews and provides signatory signoff of documentation
• Provides accurate and complete assistance to other Departments as needed
• Works 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 rooms
• 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