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Supervisor Quality Assurance (Batch Record Review) position at Regeneron, overseeing activities supporting product disposition, compliance with QA policies, and continuous improvement of processes and procedures. Requires leadership experience, quality-driven mindset, biologics manufacturing knowledge, organization, attention to detail, and ability to prioritize tasks.
Supervise and lead a team of document control professionals in a pharmaceutical setting. Coordinate review and revision of controlled documents, provide training, maintain document repositories, and ensure compliance with regulatory requirements.
Responsible for managing compensation programs, conducting data analysis, supporting HR functions, and assisting in various projects. Requires strong analytical skills, experience in equity plan administration, and proficiency in Oracle and Workday.
The Manager, QA (Supplier Quality) at Regeneron is responsible for coordinating Quality Assurance initiatives for material and supplier quality, supervising a team, implementing quality standards, and resolving quality issues. Requires 7+ years of experience in the pharmaceutical industry and a Bachelor's degree in Life Sciences or related field.
Investigation Specialist role at Regeneron in various departments including Manufacturing, Quality Assurance, Quality Control, and Technical Operations. Responsibilities include investigating non-conformances, preparing reports, analyzing data, and participating in cross-functional teams. Requires a Bachelor's degree in Life Sciences, Engineering, or related field.
Coordinate and perform certification activities for cleanroom and HEPA filtered areas, ensuring adherence to quality standards and SOPs. Analyze HEPA filter data, identify areas for improvement, and participate in creating procedures and work instructions.
The Change Control Specialist position at Regeneron involves developing strategic plans related to change control and implementing corrective actions to support manufacturing operations. Responsibilities include crafting business plans, assessing and preparing change control documentation, leading cross-functional meetings, mentoring teams, and managing projects. The role requires a Bachelor's degree in Life Sciences, Engineering, or related field with 0-2 years of experience for entry-level positions.
Design, develop, and optimize sophisticated biopharmaceutical manufacturing processes by implementing software/hardware improvements and providing technical support for automation systems. Troubleshoot and investigate manufacturing deviations and anomalies while adhering to cGMP guidelines. Support manufacturing and engineering projects and ensure compliance with system specifications and testing protocols.
Responsible for maintaining site compliance of operations including manufacturing, quality systems, quality control, and facilities maintenance. Participates in continuous improvement initiatives, interprets compliance requirements, and supports investigations of deviations related to quality. Requires a Bachelor's degree and 2+ years of relevant experience.
Collaborate with cross-functional teams to provide scientific expertise in study design, new products, and change management. Manage analytical projects, interpret data, evaluate new materials for GMP production, lead meetings, and review technical documents. Stay updated on industry guidelines for extractables and leachables. Requires BA/BS in chemistry, biology, or related field.
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