QA Associate, Quality Operations (Fully Onsite)

QA Associate - Contract - Norton, MA

Passionate about quality and compliance? Join a team where your expertise helps ensure every biopharmaceutical product meets the highest standards of safety and excellence.

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

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, and 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.

The QA Associate's responsibilities will be:

• 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 having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@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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