Aseptic QA Specialist – Shop Floor Sterility

Spectraforce Technologies; Summit (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Spectraforce Technologies in Summit West, NJ seeks a Specialist for Sterility Assurance Quality on the shop floor. You will ensure aseptic procedures, review investigations, and apply quality risk-management principles to drive compliance and issue resolution.

Requires strong cGMP knowledge, experience with deviations and CAPA, and ability to communicate technical results clearly. Weekend/off-shift availability and cross-functional teamwork are expected.

Qualifications

• Advanced knowledge of cGMP manufacturing and quality compliance.
• Experience directing improvements to quality systems.
• Ability to interpret results and recommend resolutions within GMP context.

Responsibilities

• Oversee QA on the shop floor ensuring aseptic techniques.
• Critically review investigations and generate technical conclusions.
• Knowledge of change control, deviations, investigations, CAPA management.
• Plan, organize, build relationships and multi-task effectively.
• Weekend and off-shift hours availability.

Skills

cGMP knowledge

Quality systems

Investigations

Root cause analysis

Documentation

Aseptic technique

Education

High School Degree

Job description

Spectraforce Technologies in Summit West, NJ seeks a Specialist for Sterility Assurance Quality on the shop floor. You will ensure aseptic procedures, review investigations, and apply quality risk-management principles to drive compliance and issue resolution.

Requires strong cGMP knowledge, experience with deviations and CAPA, and ability to communicate technical results clearly. Weekend/off-shift availability and cross-functional teamwork are expected.