Tech Ops and Quality - QA Associate, Quality Operations

QA Associate, Quality Operations

The QA Associate will help ensure that life-changing biopharmaceutical products are manufactured to the highest standards. The QA Associate will provide day-to-day QA support across manufacturing, validation, materials, QC, engineering and facility operations at our Norton site, partnering with cross-functional teams to maintain GMP compliance and inspection readiness.

Key Responsibilities

• Provide raw material support, including review/approval of incoming material documentation and release for GMP use.
• Deliver on-the-floor QA support to manufacturing, including area clearance and changeover operations, ensuring readiness for production activities.
• Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and quality documents.
• Generate and maintain Quality-related SOPs and controlled forms.
• Review and approve validation documents and protocol executions to confirm compliance with approved procedures and regulatory requirements.
• Review and approve QC laboratory qualification documents, including equipment qualification.
• Perform executed batch record review and approval to ensure accuracy and compliance.
• Review and approve deviations, CAPAs, Change Controls and related investigations in the quality management system.
• Support partner audits and regulatory inspections, including document retrieval and subject matter input.
• Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance.
• Collaborate with internal cross-functional teams at the Norton facility to drive continuous improvement and quality excellence.

Qualification/Skills

• Bachelor's degree in a scientific or engineering discipline (Biology, Chemistry, Biotechnology, etc.) or equivalent experience.
• 2–4 years of GMP experience in Quality, Manufacturing, or QC.
• Knowledge of cGMP regulations (21 CFR Parts 210/211/11, ICH Q7/Q10) and Good Documentation Practices.
• Strong attention to detail, organizational skills, and the ability to communicate effectively across teams.
• Experience with quality systems (e.g., Veeva, SAP) is a plus.

At Talent Burst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

Talent Burst is an equal opportunity employer committed to an inclusive and diverse workforce.