Manufacturing Quality Specialist - Remote

Overview

The Manufacturing Quality Specialist is responsible for ensuring compliance with cGMP regulations, company policies, and customer expectations by supporting manufacturing operations through documentation review, quality event management, and process oversight. This role requires expertise in upstream and downstream biologics processes, quality systems, and regulatory requirements to ensure the highest standards of product quality and compliance.

In Short

• Perform inspection, sampling, and testing on incoming materials and packaging components.
• Ensure smooth flow of raw material and critical material testing.
• Perform cleaning and sanitization of ISO areas.
• Review and release raw materials for manufacturing.
• Author and review batch records and SOPs.
• Conduct investigations into quality events.
• Participate in daily meetings with manufacturing teams.
• Perform quality assurance audits of manufacturing areas.
• Assist in cross-functional projects to resolve quality issues.
• Support manufacturing processes during critical campaigns.

Requirements

• Bachelor’s degree in Biological Sciences, Engineering, or related field.
• 3-7 years of quality assurance experience in cGMP environments.
• Strong knowledge of cGMP regulations.
• Technical expertise in biologics manufacturing processes.
• Experience with QMS investigations.
• Familiarity with quality event investigation tools.
• Strong communication skills.
• Excellent organizational skills.
• Ability to work independently and collaboratively.
• Proficiency in Microsoft Office applications.

Benefits

• Competitive salary.
• Health benefits.
• Opportunities for professional development.
• Collaborative work environment.
• Support for work-life balance.