Quality Assurance Specialist I

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:

The Quality Assurance Specialist I at MilliporeSigma in Sinking Spring will support the Quality Assurance department by completing functions such as peer reviews, raw material sampling, and cleaning. This individual will ensure that all aspects of Raw Material and Finished Product review and release are performed in accordance with approved site quality and safety standards.  Other responsibilities include environmental monitoring, maintenance of 5S and hard copy SOPs, general data entry, as well as participation in investigations as needed.  These activities are performed in accordance with approved procedures following site quality and safety standards.

- Sample raw materials, components, and finished products; complete material receipt reviews and sample submission documentation.
- Perform peer reviews and QA/QC release activities for raw materials, components, and finished products, including concurrent releases and re-evaluations.
- Monitor temperature and humidity in sampling suites and incubators; investigate out-of-specification events and maintain related records.
- Collect and conduct preliminary reviews of environmental monitoring samples; clean sampling areas and monitoring equipment.
- Support material control activities, including QA holds, rejections, damaged-container assessments, repacking, write-offs, part-number changes, and inventory updates in ERP systems.
- Review, verify, and release batch records; enter QC test results; create and approve COAs, COMs, manufacturer declarations, and production labels.
- Participate in deviation investigations, root-cause analyses, CAPA development, tracking, and effectiveness checks.
- Maintain SOPs, logbooks, indices, logs, and charts; support customer and internal audits, cross-functional meetings, inquiries, lot creation, and other quality-system activities.

Who You Are

Minimum Qualifications:

- High School Diploma or GED.

Preferred Qualifications:

- Bachelor’s Degree.  Bachelor’s Degree requirement may be substituted by applicable work experience.
- 1+ year direct Quality Assurance experience in a GMP environment.
- 2+ years of experience in a Pharmaceutical, Biopharm, or other Healthcare industry with demonstrable familiarity of cGMP’s, cGLP’s and/or related ISO/EXCiPACT requirements.
- An understanding of commercial Quality Systems and their application in a manufacturing environment.
- Good customer service skills and the ability to negotiate win-win outcomes.

Pay Range for this position: $26-$29 per hour

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.

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!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!