What are the responsibilities and job description for the Quality Assurance Associate position at AllSTEM Connections?
AllSTEM Connections is seeking a Quality Assurance Associate to work hybrid/remote (3 days onsite) in Boston, MA.
This is a 12-month contract position. Possible extension/temp-to-hire.
Hourly rate is up to $125/hour.
M-F, 8AM - 5PM.
SUMMARY:
Our confidential client is a clinical-stage biotechnology company focused on developing innovative gene editing therapies for cardiovascular disease. Leveraging advanced genetic medicine technologies, the organization is building a pipeline of transformative treatments designed to address the underlying causes of serious chronic conditions and improve long-term patient outcomes.
As a Quality Assurance Associate reporting to the Sr. Director of Quality Assurance Operations, you will play a key role in supporting quality oversight activities for the GMP manufacturing and testing of clinical trial materials performed by contract development and manufacturing organizations (CDMOs) and contract testing laboratories (CTLs). You will also support regulatory submission reviews and source data verification activities.
The ideal candidate is a collaborative quality professional with hands-on biotech GMP experience and strong communication skills, capable of partnering across internal teams and external vendors to support a growing pipeline of gene editing therapies. This role includes reviewing quality documentation and helping maintain phase-appropriate quality systems, including GxP compliance, document control, validation, quality control, and related quality operations activities.
RESPONSIBILITIES:
- Assist in Quality oversight for external GMP production and testing activities for clinical stage products and materials
- Review master batch records, executed batch records, analytical testing protocols, methods, reports, testing records, stability documentation, and other quality documentation as needed
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Perform review of Regulatory submissions and source data verification
- Assists in establishing and maintaining internal procedures in compliance with FDA, ICH, EU, and other country-specific regulations
- Other duties as assigned
QUALIFICATIONS:
- Bachelor’s degree (scientific discipline preferred) and 4 years demonstrated quality experience in GMP environment or pharmaceutical/biopharmaceutical industry
- Strong written and verbal skills
- Ability to communicate across various cross-functional teams
- Ability to work independently and drive pending actions to completion
- Experience in GXP document review
- Strong computer skills – Word, Excel, and other electronic Quality systems