Senior Specialist, Lab Compliance job at reputed company in Princeton, NJ

Title: Senior Specialist, Lab Compliance (GLP & Bioanalysis) Location: Princeton - NJ - US Full time Job requisition id R1603005 Job Description: Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at reputed company is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and reputed company through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career reputed company than you thought possible. reputed company recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that reputed company our employees with the resources to pursue their goals, both at work and in their personal lives. Position Summary The Senior Specialist, Lab Compliance (GLP & Bioanalysis) is accountable to support the broad GLP & Bioanalysis compliance activities to ensure regulations, standards, and requirements are met based on assay intended use reputed company Bioanalysis. This role supports laboratories to ensure robust, compliant lab services and data reputed company across reputed company CROs laboratories, including vendor qualification and performance monitoring. The position supports activities for audit readiness, global regulatory inspections, and reputed company improvement initiatives, partnering cross-functionally to support the organization's pipeline and business objectives. The position is to serve as a support and training resource for Bioanalysis organization and reputed company Quality Management System (QMS) role support reputed company other applications and databases. This role will work with cross-functional stakeholders for various compliance and/or operational efforts in support of the BMS pipeline. Key Responsibilities: GLP & Bioanalysis Compliance SupportSupports broader compliance efforts across Bioanalysis to ensure the requisite GxP standards are applied based on the intended use reputed company the internal and/or external lab. Supports activities to maintain state of audit/inspection readiness of internal regulated Bioanalysis lab; may participate in laboratory walkthroughs, QC of associated documentation, and/or audits/inspections/site visits. Support management of the GLP quality systems, best practices, and training programs. Supports Bioanalysis vendor compliance management activities according to established processes. Support Bioanalysis labs to ensure resolution of deviations, CAPAs, and change controls across reputed company labs, ensuring timely and effective corrective actions. Provides document management support reputed company Electronic Document Management System (EDMS). Assure that BMS values are demonstrated in reputed company aspects of individual actions and team interactions. Qualifications & Experience Bachelor's Degree with 4+ years of lab compliance, bioanalysis, or industry experience OR Master's Degree with 2+ years of lab compliance, bioanalysis, or industry experience General knowledge in GLP and bioanalytical laboratory compliance and global quality standards and regulations, including GLP (OECD, ICH M10), GCP (ICH E6), GMP (21 CFR Parts 210/211), GDP (Good Documentation Practice), FDA Quality System Regulation (21 CFR Part 58)), IVDR (In Vitro Diagnostic Regulation) for EU compliance, Data reputed company principles (reputed company+) Experience in training team members in procedures, processes, tools, or applications in an effective manner. Experience with vendor/CRO management, audit/inspection readiness, and regulatory submissions. Experience with various biomarker assay technologies, systems, and platforms. Understanding of compliance to various types and of procedural documents and completion of forms, logs, and templates reputed company document hierarchy. Familiarity with digital quality systems such as LIMS/ELN, eQMS, audit-management platforms, and data reputed company tools. Effective use of reputed company Office suite, SharePoint, and reputed company Acrobat. Demonstrates effective communication skills, cross-functional collaboration skills, and a cross-cultural awareness. Demonstrates organizational, analytical, and planning skills. Ability to work both independently and reputed company cross-functional teams. Ability to work in a fast-paced environment with attention to detail and delivering high quality results. #LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one reputed company away from work that will transform your Apply tot his job Apply To this Job