Quality Assurance Co-op Spring 2027

Randstad USA; Indianapolis (IN); On-site; USD 36,000 - 45,000; Part time

Job summary

MilliporeSigma is seeking a detail-oriented QA Co-op to join the Quality Assurance team at our Indianapolis facility. The role supports cGMP documentation systems and regulatory readiness during a 6-month coop from January 4, 2027 through June 25, 2027.

Active enrollment in an academic program is required. The successful candidate will assist with document processing, review, and change control, while gaining exposure to pharmaceutical quality systems and regulatory compliance in a controlled

Qualifications

• Currently 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 processing, editing, updating, tracking, and filing of quality documents per cGMP.
• Support document review and approval through the electronic document management system.
• Participate in change control procedures and revision history maintenance.
• Perform periodic reviews of controlled documents for regulatory compliance.
• Update the Approved Supplier List by coordinating with vendors and Inventory Management.
• Prepare documentation for regulatory inspections and internal audits.
• Contribute to continuous improvement initiatives for Quality Management Systems.

Skills

Quality Management Systems

cGMP principles

Attention to detail

MS Office

Written and verbal communication

Analytical thinking

Problem solving

Education

Bachelor's degree in Life Sciences/Quality Systems

Tools

Electronic document management systems

Job description

***THIS IS A 6-MONTH CO-OP STARTING JANUARY 4, 2027 THROUGH JUNE 25TH, 2027. TO QUALIFY, THE CANDIDATE HAS TO BE ACTIVELY ENROLLED IN AN ACADEMIC PROGRAM- NO RELOCATION STIPEND PROVIDED***

MilliporeSigma is a global leader in life science research and biopharmaceutical manufacturing. Our culture thrives on creativity and a shared passion for advancing scientific discovery. We are seeking a co-op to join our dynamic Research & Development team. This role supports the Life Science Biology franchise within MilliporeSigma.

The MilliporeSigma facility in Indianapolis specializes in contract development, manufacturing, and fill-and-finish services for complex and sterile pharmaceutical products, particularly lipid nanoparticles (LNPs) and mRNA technologies.

We are seeking a detail-oriented QA Co-op to join the Quality Assurance department of 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.

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.

Qualifications:

• Currently 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

Preferred Qualifications:

• Previous exposure to pharmaceutical or regulated manufacturing environment
• Familiarity with electronic document management systems
• Understanding of 21 CFR Part 11 compliance requirements
• Knowledge of document lifecycle management
• Experience with data entry and records management
• Gain hands-on experience with cGMP documentation requirements
• Develop understanding of pharmaceutical quality systems and regulatory compliance
• Build knowledge of document control processes in a regulated environment
• Experience the document lifecycle from creation through archival
• Network with professionals in pharmaceutical manufacturing