Parenteral Quality Assurance Floor Consultant

Job Title: Parenteral QA Floor Representative

Location: Durham/RTP, NC

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:

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

Qualifications:

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