Job Description

Job Description

Job Summary

The Manufacturing Support Associate provides hands-on support to GMP manufacturing operations within a CDMO environment. This role is responsible for owning and investigating deviations, performing detailed manufacturing batch record (MBR) reviews, and ensuring documentation accuracy and compliance. The associate partners closely with manufacturing, quality, and technical teams to maintain high-quality standards and support continuous improvement initiatives.

Responsibilities

• Lead and execute deviation investigations, including root cause analysis and deviation report writing.
• Perform comprehensive MBR reviews to ensure accuracy, completeness, and compliance with GMP requirements.
• Support documentation activities such as logbook reviews, corrections, and updates to manufacturing records.
• Collaborate with manufacturing teams to gather data, understand workflow issues, and drive timely deviation closure.
• Assist in implementing corrective and preventive actions (CAPAs) and support process improvements.
• Ensure adherence to GMP guidelines and maintain audit-ready documentation practices.
• Participate in cross-functional meetings to support production activities and resolve documentation-related issues.

Qualifications

• 3–5 years of experience in a GMP manufacturing environment (biotech, pharma, or CDMO preferred).
• Strong, hands-on experience owning and writing deviations, including root cause and impact assessments.
• Experience reviewing manufacturing batch records and supporting related documentation.
• Working knowledge of GMP regulations and manufacturing operations.

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