QA Associate / QA Associate

QA Associate - Contract - Norton, MA

Are you passionate about quality and compliance? Join a team where your expertise ensures that every biopharmaceutical product meets the highest standards of safety and excellence.

Proclinical is seeking a QA Associate in Quality Operations for a fully onsite role in the US. This position requires close collaboration with cross-functional teams to maintain GMP compliance and ensure readiness for inspections.

Primary Responsibilities

The successful candidate will play a key role in ensuring that biopharmaceutical products are manufactured to the highest quality standards. You will provide day-to-day quality assurance support across various functions, including:

• Manufacturing
• Validation
• Materials
• Quality Control
• Engineering
• Facility Operations

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.

Key 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.

If you are interested in this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

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