Senior Analyst, QC Compliance

A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made . We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.   For more information, please visit www.resilience.com Operating with a high degree of independence, the Senior Analyst, QC Compliance owns compliance activities that sustain adherence to GMPs, regulatory requirements, and internal quality systems. This role leads lab investigations, deviations, change controls, and CAPAs for QC Microbiology. The Senior Analyst acts as a technical advisor within QC Microbiology, coaches junior analysts, and builds alignment on compliance decisions affecting QC and partner functions. The Senior Analyst collaborates with cross-functional teams to drive timely closure of quality events and maintain inspection readiness.

Investigations, Deviations & CAPA Act as primary Lead Investigator/Author on Out of Specification, Laboratory, and Deviation investigations. Lead Change Controls/CAPAs end-to-end including initiation, implementation, and closure. Collaborate with Quality Assurance, Manufacturing, Validation and other cross-functional teams to complete quality records within assigned due dates. Documentation & Document Control Review QC laboratory logbooks to ensure completeness, accuracy, and compliance with Good Documentation Practices (GDP) and data integrity requirements. Manage the assessment, implementation, and documentation of compendial updates (e.g., USP, EP, JP), ensuring laboratory methods, specifications, procedures, and related documentation remain current and compliant. Author and review SOPs, Test Methods, and other controlled documents. Data Review, Trending & Reporting Compile and evaluate QC data for Annual Product Quality Reviews (APQRs). Generate quality trend reports for Water system, EM and LIR to identify recurring issues and improvement opportunities; present findings and recommendations to management. Identify systemic quality trends and lead cross-functional initiatives to address root causes. Inspection & Audit Readiness Serve as QC Microbiology SME during regulatory inspections (Health Canada, FDA, EMA) and client audits. Report significant quality events, regulatory concerns, or systemic compliance issues to the Manager, QC Compliance. Technical Leadership & Development Mentor and coach Analyst II, Analyst, and Technician team members on quality systems, investigation practices, and GMP documentation requirements. Execute QC compliance projects and perform routine laboratory testing as required to support departmental objectives. Act as compliance advisor to QC Microbiology, building alignment across QC, QA, and Manufacturing on investigation conclusions, risk assessments, and remediation approaches. Experience & Education Minimum Qualifications Advanced knowledge and demonstrated expertise in QC compliance and quality management systems, including OOS and deviation investigation, CAPA, change control, and document control. Demonstrated authorship of SOPs, Test Methods, and Change Controls. Advanced technical report writing and data analysis. Proficiency in Microbiology analytical test methodologies. In-depth knowledge of cGMPs, compendial standards (USP, EP), and regulatory expectations for biopharmaceutical drug product and drug substance testing. Demonstrated coaching and mentoring of Analyst-level staff. Demonstrated experience supporting regulatory inspections and internal audits. Ability to work with a high degree of independence and manage multiple priorities and complex tasks. Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.

Bachelor's degree or higher in