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.