QA Specialist I – Cell Therapy Operations

RoslinCT; Hopkinton (MA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan

Educational assistance

Job summary

RoslinCT is seeking a QA Specialist I – Plant Operations to provide QA support for manufacturing operations and ensure compliance with cGMP/ICH. The role focuses on batch record creation and approval, documentation control, and improving QA processes to support product disposition and shipping.

Experience in cell therapy manufacturing is preferred. The ideal candidate will join a team dedicated to developing and manufacturing cutting-edge therapies, with a comprehensive benefits package

Qualifications

• 2–5 years of QA experience in pharma/biotech with internal manufacturing; Cell Therapy experience preferred.
• Experience in Quality Assurance Operations supporting internal manufacturing.
• Ability to partner cross-functionally and provide quality support within agreed timelines to support plant activities.
• Versed in cGMP and ICH regulations / guidelines.
• Strong verbal and written communication skills.

Responsibilities

• Create, review, and maintain batch records and labels.
• Review and approval of executed batch documentation.
• Review and approval of GMP documentation such as EM exceptions, Calibration/Work Order Records, equipment activation, and process-related forms.
• Monitor implementation of QA procedures for compliance and identify improvement opportunities.
• Support product disposition, packout, and shipping.

Skills

Quality Assurance

cGMP & ICH

Batch records review

Cell Therapy experience

Cross-functional collaboration

Job description

RoslinCT is seeking a QA Specialist I – Plant Operations to provide QA support for manufacturing operations and ensure compliance with cGMP/ICH. The role focuses on batch record creation and approval, documentation control, and improving QA processes to support product disposition and shipping.

Experience in cell therapy manufacturing is preferred. The ideal candidate will join a team dedicated to developing and manufacturing cutting-edge therapies, with a comprehensive benefits package