Quality Assurance Consultant

Medasource; Pleasant Prairie (WI); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Batch Disposition QA Representative to ensure compliance with quality and safety standards in pharmaceutical production. This role involves overseeing batch disposition processes, conducting thorough reviews of batch records, and supporting investigations related to quality issues. The ideal candidate will have a strong understanding of regulatory requirements and excellent communication skills to collaborate effectively across teams. Join a dynamic environment where your expertise will contribute to the success of pharmaceutical manufacturing operations.

Qualifications

• Bachelor's degree or equivalent experience in a relevant field.
• Experience in batch disposition within pharmaceutical manufacturing.

Responsibilities

• Oversee batch disposition processes ensuring compliance with quality standards.
• Conduct reviews of batch records to confirm compliance and support investigations.

Skills

Regulatory Compliance

Quality Assurance

Communication Skills

Collaboration

Problem-Solving

Education

Bachelor's degree in a relevant field

Job description

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.

Seniority level

Not Applicable

Employment type

Contract

Job function

Manufacturing and Engineering

Industries

Pharmaceutical Manufacturing