Associate, Quality Assurance – Incoming Batch Disposition

Role Summary

Associate, Quality Assurance – Incoming Batch Disposition. Responsible for release of incoming materials using SAP and Lab systems, including active pharmaceutical ingredients, components, and excipients. Provides guidance on non-conformance investigations, change control proposals, and batch disposition activities, and supports process teams on quality matters related to incoming materials.

Responsibilities

• Maintains responsibility for a safe work environment, leading safety initiatives, and working safely; support for Health, Safety, and Environmental goals.
• Performs batch disposition of incoming materials to ensure availability of approved supply for operations.
• Leads, mentors, and coaches operations and support personnel on quality matters related to incoming materials and batch disposition.
• Provides guidance to ensure robust Quality Systems and GMP compliance.
• Participates in self-led inspections and supports internal/external regulatory inspections.
• Initiates, reviews, and/or approves GMP documents (deviations, procedures, protocols, specifications, change controls).
• Participates in continuous improvement initiatives to enhance productivity within the Batch Disposition work center/site.

Qualifications

• Required: Bachelor's degree in a science, engineering, or pharmaceutical-related field or equivalent experience.
• Required: Minimum 3 years in the pharmaceutical industry with specific batch disposition experience.
• On-site presence required.

Additional Skills

• Demonstrated understanding of cGMP regulations.
• Experience in GMP production environments.
• Experience in inventory management systems (e.g., EWM, SAP).
• Demonstrated experience in a GMP facility.
• Proficiency with applicable computer systems.
• Strong oral and written communication skills; interpersonal and teamwork abilities.
• Root cause analysis/troubleshooting skills.
• Attention to detail and ability to maintain quality systems.
• Ability to work independently or as part of a team to resolve issues.
• Technical writing and communication skills.

Education

• Bachelor's degree in science, engineering, or pharmaceutical-related field or equivalent experience.

Additional Requirements

• Primary location: Kenosha County, Wisconsin.
• Travel: Approximately 10% travel.
• Overtime as required.