Specialist, Quality Assurance

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

Benefits offered by this job

Health insurance

Paid time off (PTO)

Retirement contributions

Other prerequisites

Job summary

MilliporeSigma is seeking a Quality Assurance professional to perform quality document control and product release activities in a parenteral manufacturing environment. You will review Batch Manufacturing Records, ensure GDP compliance, and collaborate with QA, QC, Operations, clients, and suppliers to meet regulatory requirements.

The role requires 2+ years of GMP QA experience; a Bachelor’s degree is preferred. Strong communication skills and ability to work autonomously are essential.

Qualifications

• 2+ years of quality assurance experience within GMP regulated environment.
• High School Diploma or GED required.
• Knowledge of cGMPs and GDP/documentation practices.
• Ability to operate autonomously and collaborate with others.
• Excellent written and verbal communication skills.
• Bachelor's Degree preferred.

Responsibilities

• Perform thorough review of Batch Manufacturing Records and cGMP documents for commercial drug product lots.
• Evaluate batch records for accuracy, legibility, proper documentation practices and compliance.
• Identify errors and communicate corrections with Manufacturing per GDP requirements.
• Initiate deviations and investigations in the eQMS for batch record discrepancies.
• Drive continuous improvement in documentation quality with feedback and retraining recommendations.
• Track and report batch record review cycle times for on-time lot disposition.
• Maintain knowledge of product manufacturing processes and controls to support batch record review.

Skills

Strong oral and written communication

Train and qualify others

Autonomy and collaboration

Education

Bachelor's Degree

High School Diploma or GED

Tools

eQMS

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

• 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 / yearThe 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
• 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!