Quality Assurance Specialist I

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.

• 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.