Sr QA Specialist

Senior QA Specialist - Contract - Cambridge, MA

Proclinical is seeking a Quality Assurance Specialist to join our team. In this role, you will focus on maintaining quality and regulatory standards within manufacturing processes. Your expertise will be crucial in supporting manufacturing activities, ensuring compliance with cGMPs, and promoting a culture of continuous improvement. This position requires proactive communication and collaboration across departments to resolve issues efficiently.

Skills & Requirements:

• High school diploma or equivalent with relevant experience in a cGMP environment.
• Experience with quality systems and oversight of cGMP production operations.
• Strong knowledge of cGMPs and regulatory requirements.
• Ability to manage multiple projects and adapt to changing priorities.
• Proficient in SAP and batch record review.
• Excellent communication skills and ability to work in multidisciplinary teams.
• Experience in root cause analysis and vaccines is advantageous.

The Senior QA Specialist will:

• Execute activities in line with quality and regulatory standards.
• Foster a quality mindset and excellence in all tasks.
• Provide on-the-floor support for manufacturing operations.
• Review manufacturing batch records for completeness and compliance.
• Manage quality systems such as Change Control, CAPAs, Deviations, and Self-inspection auditing.
• Approve Standard Operating Procedures, logbooks, and QC data.
• Support continuous improvement and industrial excellence initiatives.
• Communicate proactively with customers to resolve issues promptly.
• Assist in batch release documentation and SAP integration.
• Ensure GMP compliance and inspection readiness.
• Coordinate QA Operations team efforts for timely product release.

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

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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