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Job Analysis:
The Senior Quality Assurance (QA) Associate Specialist at MilliporeSigma plays a crucial role in upholding and continuously enhancing the company’s Quality Management System (QMS) to ensure compliance with rigorous internal standards and external regulatory frameworks such as ISO 9001, ISO 13485, FDA, USDA, and others related to biologic derived materials. This position fundamentally exists to maintain operational integrity and drive quality practices that protect product reliability, patient safety, and regulatory adherence within a high-stakes life sciences environment. Responsibilities extend beyond routine compliance, encompassing proactive document and record control, training management, deviation and CAPA oversight, complaint investigation, and conducting or leading internal audits. The role demands a blend of technical proficiency in regulatory requirements and quality systems, alongside strong coordination and communication skills to manage cross-functional relationships successfully. Given the complex regulated environment, the candidate must navigate nuanced problem-solving scenarios—such as root cause analyses and effectiveness checks—while maintaining meticulous documentation and promoting continual improvement. Success here means not only maintaining compliance but also advancing process enhancements that reduce risks and support operational excellence. The role expects individuals who are detail-oriented, proactive, and comfortable with a dynamic balance of office and on-the-floor engagement, adapting to evolving compliance needs and company goals over time.
Company Analysis:
MilliporeSigma, the US and Canadian life sciences arm of Merck KGaA, operates at the forefront of scientific innovation, providing essential tools, products, and services that empower researchers and manufacturers in healthcare and life science sectors. Known for its extensive and integrated portfolio, the company stands as a global leader with strong commitments to cutting-edge science, sustainability, and inclusion. This market positioning means the QA role is embedded in a fast-evolving, innovation-driven environment that demands high standards of quality and compliance, without compromising agility and continuous improvement spirit. The culture is likely collaborative, diverse, and mission-focused, encouraging curiosity and inclusivity, which aligns with the role’s need for cross-functional teamwork and active engagement with various site personnel. Strategically, the Sr. QA Associate contributes directly to the company’s broader vision of delivering reliable, compliant, and innovative solutions, helping to maintain operational excellence that supports sustained growth and customer trust. The company’s strong global presence and emphasis on digital and service integration suggest that this role may also have visibility across multiple layers of the organization, offering opportunities for professional growth and increased impact. Candidates who thrive here will value science-driven impact, quality culture, and continuous learning within a dynamic and principled corporate framework.