Job Description

Job Title: QA Floor Representative

Overview:

The Parenteral QA Floor Representative will provide on-the-floor quality oversight for the manufacturing of sterile injectable drug products. This role ensures compliance with regulatory requirements and best practices for formulation, filling, and isolator technology.

Key Responsibilities:

• Provide real-time QA oversight for parenteral manufacturing, including formulation, filling, and sterile filtration.
• Ensure compliance with Good Manufacturing Practices (GMP) and sterile processing requirements.
• Support deviation management and corrective actions to maintain operational excellence.
• Guide production teams in proper use of isolator technology, cleaning validation, and sterilization validation.
• Ensure effective execution of visual inspection processes for sterile drug products.
• Work cross-functionally with engineering, operations, supply chain, and technical services teams.
• Assist in training efforts to expand the capabilities of site personnel.

Qualifications:

• Bachelor's degree in a relevant field (or equivalent experience).
• Experience in pharmaceutical QA oversight, particularly in sterile injectable manufacturing.
• Strong understanding of single-use disposable systems (SUD), CIP/SIP processes, and isolator technology.
• Experience with visual inspection and aseptic processing.
• Ability to work collaboratively and influence teams without direct authority.
• Willingness to travel as needed to support site operations. Travel could include WI, NC, IN, and other states in US.
• Flexible schedule to support 24/7 operations as required.

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