Quality Systems Analyst Resume Autumn French Quality Systems Analyst (732) 555-6418 autumn.french@example.com linkedin.com/example/autumnfrench New Brunswick, NJ 08901 STRENGTHS Document Control Managed review, approval, issuance, and retirement records, and became a dependable resource when teams needed status clarity. Audit Readiness Prepared traceable evidence for audit requests, and careful follow through helped process owners respond with confidence. Data Integrity Spotted documentation gaps in records and workflows, then routed concerns clearly so corrective action could begin. Investigation Support Built clear event chronologies from source records, giving reviewers a practical story they could verify and close. Cross Functional Coordination Connected manufacturing, quality, and technical partners around approved actions, keeping work moving when priorities shifted. SKILLS cGMP Data Integrity Change Control Audit readiness Document control Quality Assurance Quality Control Investigations Records management Risk escalation SOP revision Project closure Process optimization Time management Written communication LANGUAGES English Native 40 Spanish Intermediate 20 MY CAREER 2.9 Years Quality Systems Analyst at Meridian Biologics Manufacturing (1.2 Years) Quality Assurance Associate at Garden State Life Sciences (1.7 Years) SUMMARY Quality Systems Analyst with three years supporting cGMP regulated manufacturing through document control, records management, Data Integrity, Change Control, investigations, audit readiness, and process improvement. Administers controlled document lifecycles , revises Standard Operating Procedures , maintains traceable quality records, and supports site quality systems in fast paced production settings. Serves as a quality system superuser , resolves workflow questions, identifies potential quality risks, and escalates material concerns with sound judgment. Coordinates actions across manufacturing, quality, and technical stakeholders, helping align site procedures with broader organizational requirements. Brings a biology background, ASQ quality training, clear written and verbal communication, dependable follow through, and practical time management. Ready to contribute thoughtful quality system execution, reliable documentation, and steady operational support within a regulated manufacturing environment. EXPERIENCE Quality Systems Analyst Meridian Biologics Manufacturing July 2025 - Present New Brunswick, New Jersey Supports manufacturing and quality functions through controlled documentation, site quality system administration, audit preparation, Change Control, Data Integrity review, and improvement assignments. Serves as a site superuser while coordinating closure activities across production, quality, and technical teams. Administered controlled document lifecycles through review, approval, issuance, periodic review, and retirement under cGMP controls. Resolved quality system workflow questions by correcting metadata practices and escalating system or compliance concerns. Retrieved traceable records for audits, coordinated process owner responses, and tracked assigned actions through closure. Reviewed Change Control packages, confirming impact assessments, implementation evidence, and closure documentation before quality review. Evaluated Data Integrity risks in records and workflows, escalating potential compliance concerns for corrective follow up. Led quality improvement assignments that aligned site procedures with broader quality expectations without disrupting production schedules. Quality Assurance Associate Garden State Life Sciences October 2023 - June 2025 Somerset, New Jersey Executed Quality Assurance activities for cGMP manufacturing, with responsibility for batch records, controlled procedures, investigations, Change Control, Data Integrity, and audit support . Partnered with manufacturing personnel and subject matter experts to convert approved changes into usable, compliant documentation. Reviewed batch records and controlled documents for completeness, consistency, and adherence to approved procedures. Drafted Standard Operating Procedures with subject matter experts, translating approved process changes into clear instructions. Assembled investigation records, documented event chronology, and tracked approved actions through documented completion. Supported equipment, process, and documentation Change Controls by maintaining evidence and confirming implementation steps. Identified documentation gaps under Data Integrity principles and routed discrepancies for timely correction. Balanced audit requests, document revisions, investigations , and routine quality work within a high paced manufacturing setting. PROJECTS Site Document Lifecycle Optimization 2025 Improved document workflow practices across manufacturing and quality teams by standardizing review routing, metadata checks, approval evidence, and retirement records. Work supported clearer ownership, stronger traceability, and smoother audit preparation. Manufacturing Investigation Records Review 2024 Supported investigation documentation by organizing event records, clarifying chronology, coordinating factual input, and tracking approved actions. Work helped quality reviewers locate complete evidence and maintain reliable closure records. LEADERSHIP & AWARDS ASQ Certified Quality Improvement Associate, earned 2025, recognizing applied quality improvement knowledge. Quality Systems Improvement Recognition, received 2025 for dependable document control and closure support. Manufacturing Quality Contribution Award, received 2024 for clear investigation and procedure documentation. EDUCATION Bachelor's Degree in Biology Rutgers University GPA: 0 2023 New Brunswick, New Jersey Coursework: Cell biology, microbiology, genetics, biochemistry CERTIFICATIONS ASQ Certified Quality Improvement Associate 2025 cGMP for Manufacturing Professionals, Rutgers Continuing Studies 2024 TECHNICAL SKILLS Quality Systems: Document control, Records management, Quality Assurance Regulated Manufacturing: cGMP, cGxP, Manufacturing quality Data Integrity: ALCOA principles, Traceability, Record review Controlled Documents: Standard Operating Procedures, Work instructions, Periodic review Change Control: Impact assessment, Implementation evidence, Closure packages Audit Support: Audit readiness, Evidence retrieval, Response tracking Investigation Support: Event chronology, Root cause review, Corrective actions Quality Risk: Risk identification, Escalation, Compliance review Quality Records: Batch records, Controlled records, Approval records Process Improvement: Workflow optimization, Procedure alignment, Project closure Communication Tools: Written communication, Verbal communication, Stakeholder coordination Manufacturing Operations: Production support, Operational continuity, Off shift support SKILLS cGMP Data Integrity Change Control Audit readiness Document control Quality Assurance Quality Control Investigations Records management Risk escalation SOP revision Project closure Process optimization Time management Written communication PROFESSIONAL AFFILIATIONS ASQ, quality improvement professional affiliation supporting continued development in quality systems. Rutgers Life Sciences Community, biology alumni connection grounded in regulated science and manufacturing interests. LANGUAGES English (Native) Spanish (Intermediate) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST
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