Applied Statistics & Quality Assurance Tutor

Victor H. Nunez, Statistics Tutor

Tampa, *****, 813-***-****, *******@*******.***

SUMMARY Detail-oriented professional with extensive experience in applied statistics and quality assurance, adept at translating complex concepts into understandable terms. Proven ability to design studies, analyze data, and develop effective strategies, honed through roles in quality design and remediation engineering. Eager to leverage a strong statistical foundation and commitment to student success to provide instant, impactful AP Statistics tutoring at Varsity Tutors. WORK EXPERIENCE

Quality Design Lead

Catalent

06/2018 – Present Tampa, USA

Orchestrated and executed all requisite validations. Authored and assessed annual product reviews of drug processes to ensure compliance with specifications.

Supervised a team of 4 direct reports.

Provided leadership and Quality Assurance Management support, with responsibility for quality systems, finished product batch release, and change control.

Leveraged DFMEA (Design Failure Mode and Effects Analysis) and PFMEA

(Process Failure Mode and Effects Analysis) for risk evaluation of new products.

Authored protocols for new products and processes, evaluating usability through testing and verification.

Maintained comprehensive understanding of Medical Device Directive

(MDD)/Medical Device Regulation (MDR) and CE Mark regulations. Applied knowledge of 21 CFR Part 820, Part 11, ISO 13485, and ISO 14971. Conducted market research to ascertain market requirements for new product development.

Identified company needs and integrated market research to define objectives for new products.

Conceptualized new product ideas utilizing design prototypes. Served as a liaison for product transfers.

Led the coordination and standardization of Standard Operating Procedures

(SOPs) across multiple facilities.

Developed Quality Assurance (QA) plans for new product introductions, incorporating Advanced Product Quality Planning (APQP) specific to customer requirements.

Supported quotation processes by contributing to the design and implementation of processes.

Reviewed all supplier and customer discrepancies.

Provided technical support for quality-related customer issues. Sampled diverse materials, manufacturing processes, and design tolerances to identify optimal solutions aligning with new product briefs. Designed reviews to enhance product design effectiveness. Scrutinized project steps to ensure proper definition of control plans. Fine-tuned designs to prepare them for production. Delivered product specifications and procedures to the manufacturing team for production.

Analyzed existing products to identify areas for improvement and updated current documentation.

Established quality control criteria and safety guidelines, ensuring team adherence.

Ensured accurate determination of validation testing scope and sample size. Collaborated with cross-functional teams to integrate reliability for risk mitigation.

Incorporated specification testing into validation protocols where feasible. Participated in validation and equipment qualification programs at client sites.

Facilitated design review meetings to ensure proper establishment of product specifications.

Provided Design Quality (Design Assurance) Engineering project leadership for successful new product development and commercial launch, acting as a Quality Core Team member on New Product Development (NPD) projects. Developed design control tools for global application of harmonized design control processes.

Delivered Quality Engineering project leadership to ensure proper application of design controls, risk management, and the investigation/correction of design failures/challenges. Demonstrated understanding of equipment lifecycle management, calibration, maintenance, cleaning, and validation. Possessed expertise and working knowledge of current Good Manufacturing Practice (cGMP) guidelines and Quality Systems meeting global regulatory expectations, including 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP 5 requirements.

Executed investigations to ascertain the effectiveness of identified root causes for specific Corrective and Preventive Actions (CAPAs). Applied appropriate root cause analysis during investigations of deviations, suspected product defects, and other problems.

Authored investigation reports and evaluated the effectiveness of identified root causes in resolving manufacturing issues.

Assisted in investigations of noncompliance and nonconformance. Prepared audit reports detailing findings.

Conducted investigations to assess the effectiveness of probable root causes.

Reviewed validation and quality process deviations to ensure compliance. Examined designs of experiments to ensure the use of valid statistical techniques.

Investigated nonconformances to evaluate if root causes would prevent recurrence of quality issues.

Prepared investigation reports.

Evaluated investigation findings and trends.

Documented all training on investigation procedures and root cause analysis techniques.

Presented investigation findings in group meetings. Reviewed batch record investigations for completeness. Analyzed CAPA system data to identify trends, recurrences, and the effectiveness of root cause analyses.

Reviewed Medical Device Reports (MDRs) for items critical to quality, ensuring compliance in timing, reporting, and presentation of corrective action evidence.

Assessed Design History Files (DHFs) to determine if robust design and corrective action systems were maintained.

Performed high-level assessments of quality data to identify unfavorable trends in nonconformance, complaints, and other quality issues posing regulatory risk.

Created Statistical Analysis Plans (SAP) in accordance with ICH guideline E9.

Managed the routing of SAPs for signatures.

Prepared the table of contents for SAPs.

Ensured SAPs included background information related to the protocol, purpose of analysis, study objectives, endpoints, methods, sample size, and summary of study data.

Assisted in and reviewed the preparation of clinical trial documents and protocols for oncology studies (Phase 2 and 3).

Identified biomarkers for prostate cancer oncology therapy. Generated protocols to support Phase II clinical trials assessing oncology treatment safety and efficacy.

Managed the data science team.

Assessed vendor quality against company specifications. Determined sample size for Phase 3 clinical trials. Utilized Area Under the Curve (AUC) for evaluating the effectiveness of oncology therapy drugs.

Employed SAS programming for sample size calculation and randomness. Executed SAS programs to define statistical methodologies for hypothesis testing protocols evaluating new drug effectiveness. Remediation Lead

Teleflex-Contract Remote

07/2017 – 05/2018 Tampa, USA

Delivered training in Statistical Process Control (SPC) at a Mexico facility. Demonstrated expertise with FDA audits and knowledge of current ICH, EU, and US regulatory requirements.

Supervised a team of 3 direct reports.

Reviewed clinical trial data to generate change request forms and protocols. Developed applicable endpoints for testing hypotheses and evaluating clinical studies.

Authored supplier quality plans and established statistical techniques to enhance the quality of safety-critical components. Executed quality agreements.

Spearheaded supplier qualification and certification efforts. Monitored suppliers' quality performance and recommended corrective actions for quality system improvement.

Evaluated audit process elements to ensure proper adherence. Assisted in investigations of noncompliance.

Authored reports detailing audit findings.

Reviewed validation and quality process deviations to ensure compliance. Collaborated with cross-functional teams to determine acceptance criteria for validation deviations, ensuring compliance.

Included process capability testing in validation protocols where feasible. Authored and evaluated investigations, deviations, complaints, Commercial Off-The-Shelf (COTS) items, Out-of-Specification (OOS) results, and stability trending.

Prepared Statistical Analysis Plans (SAP) during drug development support. Provided Quality review for validation and maintenance documents of computerized systems.

Conducted reviews of engineering documents required for new facility implementation.

Participated in validation and equipment qualification programs at client sites.

Served as the QA department's Subject Matter Expert for reviewing and approving validation protocols.

Managed the qualification and SOPs for new equipment, computers, and process validation.

Provided validation guidance and training to QA GMP Staff. Approved change control and validation procedures. Executed and supported validation activities, including data trending, analysis, and interpretation.

Performed deviation investigations and resolutions through the CAPA system.

Trained personnel on investigations, deviations, CAPAs, and root cause analysis techniques.

Supported the quality department in reviewing investigations, deviations, and root cause analysis techniques applied to CAPAs or nonconformances. Maintained the Quality Management System, including incident and CAPA management, to ensure compliance of clinical trial projects and associated systems with Good Clinical Practice (GCP) and SOP requirements. Reviewed and prepared company SOPs pertaining to clinical trials, production activities, and design controls.

Created Validation Master Plans and Validation Project Plans to identify and complete required validation tasks for corporate projects within established timelines.

Quality System Expert

Molnlycke

01/2017 – 06/2017 Norcross, USA

Mentored peers on understanding 21 CFR Part 11, 21 CFR 211, 21 CFR 210, and ICH guidelines.

Collected and analyzed information required for ISO 9001 and ISO 13485 certification.

Prepared and executed Statistical Analysis Plans (SAP). Analyzed data utilizing statistical software such as AdaM. Interpreted genetic data and disease rates.

Designed clinical trials to evaluate new drugs.

Investigated nonconformances to determine if root causes would prevent issue recurrence.

Authored investigation reports and performed investigations on nonconformances or CAPAs.

Assessed probable root causes for investigations.

Maintained and updated the critical supplier audit system and schedule, conducting supplier audits to drive process standardization, waste elimination, and continuous improvement.

Evaluated investigation and complaint findings and trends. Designed and reviewed clinical trial data to assess improvements in new drugs or medical devices.

Generated tables, figures, and listings (TFL) when preparing SAPs for clinical data review.

Participated in the planning, collection, interpretation, and implementation of research studies.

Remediation Engineer

Cook Medical-Contract

06/2016 – 12/2016 Bloomington, USA

Authored statistical methodologies for new product designs. Provided cross-functional collaboration with IT, engineering, validation, and supplier groups.

Developed supplier quality plans and established statistical techniques to enhance the quality of safety-critical components. Signed quality agreements.

Investigated supplier issues that resulted in nonconformance. Served as a Subject Matter Expert during internal, supplier quality system, and external audits, as assigned.

Led supplier qualification and certification efforts. Reviewed supplier quality performance and recommended corrective actions to improve their quality systems.

Reviewed protocols and contributed to statistical analysis sections, generating study randomization schemes when appropriate. Provided independent validation of the statistical content in study documents, including randomization, study reports, briefing documents, patient brochures, publications, and other externally delivered content. Trained engineers on the application of statistical methodologies. Reviewed corrective actions and root cause analyses. Prepared and issued audit reports.

Determined appropriate sample sizes for studies based on clinical trial phases.

Utilized single or double arm study designs.

Reviewed innovative/adaptive statistical designs to ensure compliance with clinical study criteria.

Employed biomarkers for endpoint determination.

Analyzed integrated study results.

Remediation Engineer

Medtronic

01/2015 – 05/2016 Boulder, USA

Reengineered the complaint trending process to enhance user-friendliness and effectiveness.

Remediated deficiencies in CAPA systems by assessing the corrective actions employed.

Reviewed and assessed quality systems for compliance with regulatory requirements and industry best practices.

Instructed engineers on the use of control charts for trending and monitoring complaints.

Recommended statistical techniques to management for detecting unfavorable trends.

Designed a robust statistical technique capable of handling departures from normal data behavior.

Participated in project solutions to ensure compliance with budget and regulations.

Developed and delivered training on strategies to enhance business operations.

Reviewed design control requirements, including design verification, validation, risk management, and design reviews.

Evaluated the utilization of FMEAs for managing design process risks. Implemented control charts for detecting nonconformance trends. Assessed Six Sigma tools for promoting continuous improvement in design control.

Executed Six Sigma projects focused on reducing variation in product specifications.

Verified the validity of root cause analysis methodologies used for nonconformances.

Authored investigations from CAPAs and verified the effectiveness of corrective actions and root causes employed.

remediation engineer, quality expert, director of quality and quality engineer manager

Upsher Smith Labs, Terumo, Watson Pharmaceutical and Baxter Healthcare Accumulated experience as a remediation engineer, quality expert, director of quality, and quality engineer manager.

EDUCATION

NCU

Ph.D., Quantitative Business and Management

02/2003 – 05/2006 Prescott, USA

Rutgers University

Master of Science, Applied Statistics

02/1998 – 05/2002 Piscataway, USA

Rutgers University

Master of Science, Industrial Engineering

02/1980 – 05/1984 Piscataway, USA

SKILLS Data analysis Design Quality

Clinical Data Statistical Methods

Risk Assessment

Certified quality manager

University of Manitoba

Certified quality engineer

American Society of Quality

Certified reliability engineer

American Society of Quality

Six-sigma black belt

American Society of Quality

CERTIFICATES

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