Job Description
Job Title: Batch Disposition QA Representative Location: Concord, NC
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.
Job Tags
Flexible hours,
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