Quality Assurance Consultant

Job Title:
Batch Disposition QA Representative

Location: Kenosha, WI area

Overview:

The Batch Disposition QA Representative will oversee batch disposition and release processes, ensuring compliance with quality, regulatory, and safety standards for commercial pharmaceutical production.

Key Responsibilities:

• Execute batch disposition processes, ensuring timely decision-making on product release.
• Conduct thorough reviews of batch records and associated documentation to confirm compliance.
• Ensure adherence to regulatory requirements and company policies for batch disposition and release.
• Support investigations related to batch quality issues, deviations, and non-conformances.
• Collaborate cross-functionally to streamline batch disposition processes and reduce cycle times.
• Assist in training personnel on quality standards and batch disposition procedures.

Qualifications:

• Bachelor's degree in a relevant field (or equivalent experience).
• Experience in batch disposition and batch release within a pharmaceutical manufacturing environment.
• Strong understanding of regulatory requirements for commercial pharmaceutical products.
• Ability to assess and interpret quality and compliance data for informed decision-making.
• Excellent communication and collaboration skills to work effectively across teams.
• 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.

Not Applicable

Contract

Manufacturing and Engineering

Pharmaceutical Manufacturing