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.