QA Shop Floor Specialist - Cell Therapy (Contract)

Spectraforce Technologies; Harvard (MA); On-site; USD 55,104 - 82,656; Full time

Job summary

Spectraforce Technologies in Devens, MA is seeking a Contractor Field QA Specialist for the Cell Therapy Facility. You will ensure quality activities align with cGMP, perform real-time batch record reviews, and collaborate with operations to resolve manufacturing issues.

The role requires strong authorship, decision-making, organization, and the ability to navigate FDA regulated quality environments. 6-month contract with potential conversion based on performance.

Qualifications

• High School Degree required.
• Relevant college or university degree preferred.
• Minimum 2 years in a Quality Assurance role.
• FDA regulated cGMP warehousing/quality knowledge required.
• Independent, self-directed work style with strong decision-making.

Responsibilities

• Perform QA shop floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.
• Authorship capability to review investigations and produce technical conclusions aligned with Quality risk management.
• Plan, organize, and build relationships to support manufacturing quality.

Skills

QA shop floor

cGMP

Investigations & CAPA

Documentation review

Quality risk management

Problem solving

Planning & organizing

Cross-functional collaboration

Education

High School Degree

Relevant college or university degree preferred

Job description

Spectraforce Technologies in Devens, MA is seeking a Contractor Field QA Specialist for the Cell Therapy Facility. You will ensure quality activities align with cGMP, perform real-time batch record reviews, and collaborate with operations to resolve manufacturing issues.

The role requires strong authorship, decision-making, organization, and the ability to navigate FDA regulated quality environments. 6-month contract with potential conversion based on performance.