QA Co-op: cGMP Documentation & Compliance

Randstad USA; Indianapolis (IN); On-site; USD 34,000 - 44,000; Full time

Job summary

MilliporeSigma in Indianapolis, IN is seeking a detail-oriented QA Co-op to join the Quality Assurance team at our commercial drug product manufacturing facility. The successful candidate will assist in maintaining the integrity and efficiency of our cGMP documentation systems while gaining valuable experience.

The role offers exposure to document control, regulatory support, and continuous improvement initiatives within a regulated manufacturing environment.

Qualifications

• Pursuing a Bachelor's degree in Life Sciences, Quality Systems, or related field.
• Basic understanding of Quality Management Systems and cGMP principles
• Strong attention to detail and organizational skills
• Proficiency with Microsoft Office applications (Excel, Word, PowerPoint)
• Excellent written and verbal communication skills
• Ability to follow established procedures and maintain confidentiality
• Demonstrated analytical thinking and problem-solving abilities

Responsibilities

• Assist in the processing, editing, updating, tracking, and filing of quality documents according to cGMP requirements.
• Support the document review and approval process through the electronic document management system.
• Participate in document change control procedures and revision history maintenance.
• Assist in periodic reviews of controlled documents to ensure compliance with current regulations.
• Update the Approved Supplier List (ASL) by working with venders and colleagues, comparing to what is in the Inventory Management System.
• Help prepare documentation for regulatory inspections and internal audits.
• Contribute to continuous improvement initiatives for Quality Management Systems Team.

Skills

Dashboards

Smartsheets

Sharepoint

Artificial Intelligence

Document review

Education

Bachelor's degree in Life Sciences, Quality Systems, or related field

High School

Tools

Sharepoint

Smartsheets

Job description

MilliporeSigma in Indianapolis, IN is seeking a detail-oriented QA Co-op to join the Quality Assurance team at our commercial drug product manufacturing facility. The successful candidate will assist in maintaining the integrity and efficiency of our cGMP documentation systems while gaining valuable experience.

The role offers exposure to document control, regulatory support, and continuous improvement initiatives within a regulated manufacturing environment.