QA Associate, Quality Operations (Fully Onsite)

Passionate about quality and compliance? Join a team where your expertise helps ensure every biopharmaceutical product meets the highest standards of safety and excellence. This is a fully onsite contract role in Norton, MA.

Responsibilities

• Review and approve incoming material documentation and release raw materials for GMP use.
• Provide on-the-floor QA support during manufacturing processes, including area clearance and changeover operations.
• Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and other quality documents.
• Create and maintain Quality-related SOPs and controlled forms.
• Review and approve validation documents and protocol executions to ensure compliance with procedures and regulatory requirements.
• Oversee QC laboratory qualification documents, including equipment qualification.
• Perform executed batch record reviews and approvals to ensure accuracy and compliance.
• Review and approve deviations, CAPAs, change controls, and related investigations within the quality management system.
• Support partner audits and regulatory inspections by providing document retrieval and subject matter expertise.
• Approve work orders in the maintenance system to verify equipment maintenance and calibration compliance.
• Collaborate with internal teams to drive continuous improvement and uphold quality excellence.

Requirements

• Bachelor's degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Biotechnology) or equivalent experience.
• Familiarity with cGMP regulations (21 CFR Parts 210, 211, 11), ICH Q7-Q10, and Good Documentation Practices.
• Strong attention to detail, organizational skills, and effective communication abilities.
• Experience with quality systems such as Veeva or SAP is a plus.