Specialist, Quality Assurance

MilliporeSigma; Indianapolis (IN); On-site; USD 69,000 - 111,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Retirement contributions

Other prerequisites

Job summary

MilliporeSigma in Indianapolis is seeking a Quality Document Control and Product Release specialist for a complex parenteral manufacturing facility. You will perform Batch Record Review, Product Release, Document Control/Archival, investigations/CAPAs and Training to ensure compliance with regulatory requirements.

You will collaborate with QA, QC, Operations, Clients and Suppliers to establish and maintain release requirements and ensure products meet specifications.

Qualifications

• High School Diploma or GED required.
• 2+ years of quality assurance experience in GMP environment.
• Bachelor’s degree preferred.

Responsibilities

• Perform Batch Manufacturing Record review and product release per site SOPs.
• Review documentation for accuracy, GDP compliance and approval criteria.
• Initiate deviations/investigations in eQMS and communicate findings.
• Collaborate with QA, QC, Operations, clients and suppliers to ensure release readiness.
• Monitor batch record cycle times to support on-time disposition.

Skills

Quality assurance

Oral and written communication

Education

High School Diploma or GED

Bachelor's Degree

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma.

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

In this role you will perform Quality Document Control and Product Release activities within a complex parenteral manufacturing facility, including Batch Record Review and Product Release, Batch Record Issuance, Document Control/Archival, and related investigations/CAPAs and Training. The position collaborates with other QA personnel, Quality Control, Operations, Clients, and Suppliers to establish and maintain requirements for product release and document management. Responsible for ensuring that all products manufactured and/or supported meet established specifications and regulatory requirements.

Responsibilities Include But Are Not Limited To

• Perform thorough, quality review of completed Batch Manufacturing Records (MPCRs) and associated executed cGMP documents for commercial drug product lots in accordance with site SOPs and applicable regulatory requirements.
• Evaluate completed batch records for accuracy, completeness, legibility, proper documentation practices (GDP), and compliance with approved manufacturing instructions, in-process specifications, and acceptance criteria.
• Identify, document, and communicate errors, omissions, and discrepancies found during batch record review, working directly with Manufacturing personnel and frontline supervisors to initiate timely and appropriate corrections in compliance with GDP requirements.
• Initiate or support the initiation of deviations and investigations in the eQMS for batch record discrepancies that cannot be corrected via standard GDP correction practices, ensuring proper escalation and documentation.
• Collaborate with the Batch Record Review team and Manufacturing to drive continuous improvement in documentation quality, reducing recurring errors through targeted feedback, trend analysis, and retraining recommendations.
• Track and report batch record review cycle times to support on-time lot disposition and maintain alignment with established release timelines.
• Maintain working knowledge of the product-specific manufacturing processes, equipment, and in-process controls associated with all commercial products manufactured at the site to support effective and knowledgeable batch record review.

Who You Are

Minimum Qualifications:

• High School Diploma or GED.
• 2+ years of quality assurance experience within GMP regulated environment.

Preferred Qualifications

• Bachelor’s Degree.
• Knowledge of product-specific manufacturing processes, equipment, and in-process controls associated with commercial/clinical products manufactured to support effective and knowledgeable batch record review preferred
• Ability to operate with a high level of autonomy and collaborate effectively with others.
• Essential knowledge of cGMPs.
• Strong oral and written communication skills, including internal and external interface.
• Ability to train and qualify others in pharmaceutical manufacturing quality activities.
• Strategic perspective with self-motivation, resilience, team orientation, and results-driven approach.

Pay Range for this position: $69,200 - $110,900 / year

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other prerequisites.

What we offer:

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!