Description

You will ensure manufacturing quality through batch record review, documentation management, and process investigations.

Responsibilities

• Conduct initial real-time reviews of batch records and provide immediate feedback on manufacturing operations.
• Draft and maintain policies, Standard Operating Procedures (SOPs), forms, and job aids.
• Investigate manufacturing occurrences and track errors to provide data for quality metrics.
• Coordinate manufacturing needs with QC-Equipment and QC-EM teams.
• Ensure manufacturing staff remain current on required training and implement operational best practices.

Required Skills

• 5+ years of experience in a quality assurance role.
• Strong knowledge of GMP standards.
• Experience with ACT Quality Systems.
• Proficiency in technical writing for SOPs and quality documentation.
• Ability to maintain annual competencies in quality functions and EHS LMS modules.
• Degree in any field.

Preferred Skills

• Experience using MasterControl.
• Background in Tissue Culture and Cell Culture.

Key Skills

Education

Any Gradute