GMP Cleanroom Manufacturing Associate

Spectraforce Technologies, Inc.; Summit (NJ); Vor Ort; USD 25.000 - 30.000; Vollzeit

Zusammenfassung

Spectraforce Technologies, Inc. is seeking a Manufacturing Associate to produce blood component lots in a GMP cleanroom environment under supervision. The role involves aseptic processing, shift-based responsibilities, and strict adherence to GDPs and quality investigations.

The position requires a Bachelor's or equivalent, basic biology/chemistry knowledge, and proficiency in MS Office. Training includes a Monday–Friday schedule with transition to a quad shift, located in Summit, NJ.

Qualifikationen

• Entry-level prerequisites.
• Knowledge of biology, chemistry, medical or clinical practices.
• Experience or familiarity with cGMP/FDA regulated environments.
• Proficient in technical writing and MS Office applications.

Aufgaben

• Production of blood component lots through cell culture, harvest, and cryopreservation.
• Aseptic technique is required for tube-most activities: welding, connections, and transfers, at minimum.
• Weighs and measures in-process materials to ensure proper quantities are added/removed.
• Adheres to the production schedule ensuring on-time, internal production logistics.
• Records production data and information in a clear, concise, format according to proper GDPs.
• Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
• Leads a team within a designated function of manufacturing, however, supervision will be managed by the shift Supervisor.
• No direct reports will be assigned to this job role.
• Performs other tasks as assigned.

Kenntnisse

Cell culture basics

cGMP/FDA knowledge

Basic math skills

Technical writing

MS Office

Biology basics

Ausbildung

Bachelor's degree

Associate/Medical Technical degree

High School diploma/GED

Jobbeschreibung

Spectraforce Technologies, Inc. is seeking a Manufacturing Associate to produce blood component lots in a GMP cleanroom environment under supervision. The role involves aseptic processing, shift-based responsibilities, and strict adherence to GDPs and quality investigations.

The position requires a Bachelor's or equivalent, basic biology/chemistry knowledge, and proficiency in MS Office. Training includes a Monday–Friday schedule with transition to a quad shift, located in Summit, NJ.