QA Associate (Part Time)

Location: Kalamazoo, MI

Pay Rate: $19-20/hour

About the role

Responsible for supporting the Quality Assurance group in maintaining the Quality Management Systems. This role ensures that manufacturing and QC activities for the production and testing of active pharmaceutical ingredients for human use are in compliance with established company procedures and applicable GMP and ICH regulations.

Responsibilities

• Review laboratory records for raw materials and disposition raw materials in accordance with approved procedures
• Coordinate and prepare records for off-site storage, including inventory documentation and shipment to Iron Mountain
• Support data collection and compilation activities for campaign reporting
• Support the Quality Assurance group in maintaining Quality Management Systems
• Assist the Quality Assurance group in ensuring site compliance with cGMPs and ICH guidelines at all times, and support site inspection readiness

Requirements

• Associate's degree in a science-related field or equivalent experience; Bachelor's degree in Biology, Biochemistry, or Chemistry preferred
• 0-3 years' experience in a pharmaceutical quality environment (quality control and/or quality assurance)
• Working knowledge of cGMP, ICH, and industry best practices preferred
• Experience with clinical and commercial cGMP requirements preferred

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply.

Pay

$19-20/hour

Schedule

Part-time, 4-5 hours per day