GMP Cleanroom Manufacturing Specialist

Spectraforce Technologies; Summit (NJ); On-site; USD 24,796 - 35,817; Full time

Job summary

Spectraforce Technologies in Summit, NJ is seeking a Manufacturing Associate to support production of blood component lots in a GMP cleanroom. The role involves set-up and operation of equipment, adherence to GDPs, and collaboration within a cross-functional team.

Training lasts 1–6 weeks with initial hours 9:00 AM–5:00 PM, transitioning to quad shifts. Candidate should have a science background and be comfortable with cGMP environments, data recording, and quality investigations.

Qualifications

• Bachelor's degree or equivalent in a science/engineering field required.
• Background in biology, chemistry, medical or clinical practices preferred.
• Experience with GMP/computerized documentation with GDPs ideal.

Responsibilities

• Set up and operate equipment to support production of blood component lots.
• Support deviation investigations and timely CAPA closures within shift.
• Maintain aseptic technique and ensure proper handling of materials and transfers.
• Record production data clearly according to GDPs and SOPs.
• Work in a cross-functional team to meet shift schedules and quality standards.

Skills

Cell culture basics

Aseptic technique

GMP knowledge

MS Office

Biology background

Team collaboration

Quality investigations

Documentation

Communication

Education

Bachelor's degree

Associate/Medical Technical degree with 3 years manufacturing experience

High School diploma/GED with 2 years manufacturing experience

Job description

Spectraforce Technologies in Summit, NJ is seeking a Manufacturing Associate to support production of blood component lots in a GMP cleanroom. The role involves set-up and operation of equipment, adherence to GDPs, and collaboration within a cross-functional team.

Training lasts 1–6 weeks with initial hours 9:00 AM–5:00 PM, transitioning to quad shifts. Candidate should have a science background and be comfortable with cGMP environments, data recording, and quality investigations.