Quality Specialist- 3rd shift

Overview MilliporeSigma is seeking a QA Specialist to work with various internal departments to improve and execute processes in compliance with cGMP regulations (21 CFR 210, 211, Part 11) and ICH Q7. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Responsibilities Support QA on the floor activities in manufacturing. Review batch records during manufacturing events and postproduction for completeness and accuracy based on GMP requirements to ensure product and process quality. Review and approve QC data to support batch disposition. Execute batch and raw material disposition decisions. Provide quality oversight and support for new product introductions as the primary quality point of contact. Write, review, and approve operating procedures, manufacturing documents, technical transfer protocols, and other controlled documents under a Quality Management System (QMS). Handle release activities for cGMP products and raw materials. Review and approve master packaging formulas, master shipping records, and master manufacturing formulas. Manage document and label issuance activities. Interact with production and laboratory personnel to ensure effective communication and feedback for quality-related services to internal customers. Monitor product quality issues and collaborate on resolutions. Respond to quality-related customer questions as needed. Physical Attributes Environmental conditions will vary: typically 10%–30% Office Environment and 70%–90% in Production, QC, and Packaging. Who You Are Minimum Qualifications: Bachelor’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or related life science discipline. 5+ years of quality experience. OR Master’s Degree in Life Sciences, Chemistry, Pharmacy, Chemical Engineering, Process Engineering, or related life science discipline. 2+ years of quality experience. Preferred Qualifications Knowledge of ICH Q7 and API knowledge/experience. TrackWise and SAP experience. Proficiency in MS Word, MS Excel, MS PowerPoint and ability to learn other application software. Excellent verbal and written communication and customer interfacing skills. Experience writing technical documentation and reports. Ability to manage multiple tasks/priorities simultaneously. Strong problem-solving, time management, and negotiation skills. Capacity for independent work. Data analysis, presentation, and experimental design knowledge. Compensation Pay Range: $62,500.00 – $93,700.00. The offer range represents the anticipated base pay; actual compensation is determined by location, experience, education, skills, and other factors. Position may be eligible for sales or performance-based bonuses. Benefits include health insurance, paid time off (PTO), retirement contributions, and other perquisites. What We Offer We are curious minds from diverse backgrounds, perspectives, and life experiences. We believe this variety drives excellence and innovation. We are committed to creating access and opportunities for all to develop and grow at your own pace, fostering a culture of inclusion and belonging that empowers everyone to work their magic and contribute to human progress. Apply now and become part of a team dedicated to Sparking Discovery and Elevating Humanity! #J-18808-Ljbffr MilliporeSigma