Quality Assurance Co-op

Randstad USA

Indianapolis (IN)

On-site

USD 34,000 - 44,000

Full time

8 days ago
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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

***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*** At MilliporeSigma, they are at the forefront of life sciences, working tirelessly to tackle the industry's toughest challenges. By collaborating with the global scientific community, they strive to enhance health access worldwide. Their mission is clear: to equip scientists and engineers with top-notch lab materials, technologies, and services, making research and biotech production simpler, faster, and more successful. With a dedication to shaping the future of drug development, they’re with our customers every step of the way, pioneering tomorrow's possibilities.

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.

Required 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
Learning Opportunities:
  • 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

salary: $25 - $32 per hour

shift: First

work hours: 8 AM - 5 PM

education: High School

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 (6 months of experience is preferred)
  • smartsheets (6 months of experience is preferred)
  • Sharepoint (6 months of experience is preferred)
  • Artificial Intelligence (6 months of experience is preferred)
  • document review (6 months of experience is preferred)
Qualifications
  • Years of experience: 0 years
  • Experience level: Entry Level

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.

Experience
  • Entry Level
Education
  • High School (required)
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