Co-op, Site Compliance and Operations

About the role

The Manufacturing Co-op – Audit, Training & Compliance supports compliance-related activities within the manufacturing department, including audit readiness, training coordination, and adherence to GMP requirements. This role assists in maintaining inspection-ready status and ensuring timely completion of assigned compliance tasks.

Responsibilities

• Support audit and inspection readiness activities, including walkthroughs, documentation review, and tracking of audit observations
• Assist in drafting and tracking audit responses, CAPAs, and action items
• Monitor training compliance in different departments and follow up on overdue training
• Coordinate with department training coordinators and support timely assignment and completion of SOP training in the learning management system (e.g., MC)
• Assist in maintaining GMP documentation, including logbooks, forms, and SOP alignment
• Support investigations related to training gaps as applicable
• Participate in routine area inspections to ensure adherence to GMP and facility standards
• Collaborate with cross-functional teams (QA, QC, F&E, Manufacturing) on compliance-related initiatives

Requirements

• Pursuing a degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Engineering, or related field
• Basic understanding of GMP principles and pharmaceutical manufacturing is preferred
• Strong attention to detail and organizational skills
• Good communication and ability to work cross-functionally
• Proficient in Microsoft Office (Excel, Word, PowerPoint)

Skills

• Attention to detail and data accuracy
• Accountability and proactive follow-up
• Understanding of compliance and quality mindset
• Ability to manage multiple tasks in a fast-paced environment

Pay

The anticipated salary range for this position is $20 to $30 an hour.