QA Associate, Quality Operations

QA Associate, Quality Operations - Contract - Norton, MA

Champion GMP excellence to keep biopharmaceutical manufacturing inspection‑ready and compliant.

Proclinical is seeking a QA Associate, Quality Operations to support the manufacturing of biopharmaceutical products in MA. This position focuses on quality assurance activities across manufacturing, validation, materials, QC, engineering, and facility operations.

Primary Responsibilities:

The successful candidate will collaborate with cross-functional teams to ensure compliance with GMP standards and maintain inspection readiness.

Skills & 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.

The QA Associate's responsibilities will be:

• Review and approve incoming material documentation for GMP use.
• Provide on-the-floor QA support for manufacturing, including area clearance and changeover operations.
• Review and approve SOPs, master batch records (MBRs), specifications, risk assessments, and other quality documents.
• Generate and maintain Quality-related SOPs and controlled forms.
• Review and approve validation documents and protocol executions to ensure regulatory compliance.
• Approve QC laboratory qualification documents, including equipment qualifications.
• Perform executed batch record reviews 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 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 standards.

If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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