Senior Quality Assurance Representative

MilliporeSigma; 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 perquisites

Job summary

MilliporeSigma in Indianapolis seeks a QA on-the-floor oversight role to ensure compliant manufacturing activities. You will review documentation, perform line clearances, and monitor aseptic processes to reinforce best practices in a GMP environment.

The position emphasizes aseptic technique expertise, documentation discipline, and collaboration with manufacturing teams to maintain product quality and regulatory compliance.

Qualifications

• Bachelor's degree in biology, chemistry or life sciences with 2+ years GMP experience.
• Alternative: high school diploma with 5+ years GMP experience.
• Experience with Excel, Word and Access preferred.
• Familiarity with SAP and quality management systems a plus.

Responsibilities

• Review documented steps to verify execution and proper documentation.
• Perform line clearances and room releases for manufacturing use.
• Review logbooks to confirm activities are completed and recorded.
• Monitor formulation and filling for cGMP compliance.
• Provide aseptic core monitoring and SME guidance on aseptic practices.

Skills

Quality Assurance

cGMP compliance

Aseptic technique

Documentation practices

Education

Bachelor's Degree in Biology, Chemistry, or Life Science

High School Diploma or GED with 5+ years GMP experience

Tools

Microsoft Excel

Microsoft Word

Microsoft Access

SAP

Quality Management Systems

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

This role provides day shift support as quality assurance on-the-floor oversight for manufacturing activities at the facility.

Responsibilities Include But Are Not Limited To

• Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed.
• Performs and documents line clearances and room release for manufacturing use.
• Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented.
• Monitors the formulation and filling processes to ensure cGMP compliance.
• Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators. Requires qualification in aseptic gowning and certification as an aseptic processing SME.
• Observers, reports, and documents operator cleaning and disinfection practices.
• Documents, reports, and trends observations stemming from Quality Oversight.
• Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices.
• Monday - Friday 10am - 6:30pm.

Physical Attributes

• Lift and/or move up to 25 pounds.
• Wear appropriate Personal Protective Equipment.

Minimum Qualifications

• Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience.

OR

• High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience.

Preferred Qualifications

• Experience with computer software applications including Microsoft Excel, Word, and Access.
• Experience with Quality Management computer systems and SAP.
• Experience with EU Annex 1 classified areas A, B, C, and D including acceptable aseptic behaviors, practices, and gowning.

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 perquisites.

For more information click here.

RSREMD

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!