Quality Assurance Manager

Kathleen Yanakis

661-***-**** *.*******@*****.***

Executive Summary

I've acquired a broad Quality Assurance experience with tenure in many sectors, namely Aerospace (6 yrs), Oil Industry (EH&S), Medical Devices (12 yrs), Personal Care Products manufacturing, Pharma and Biological Tissues.

I’ve developed wide-ranging skillsets in my Quality Assurance Management career, namely:

• Development, implementation, maintenance and sustenance of QMS in support of Operations

• Management of internal, 2nd, and 3rd-party Certification audits (AS and ISO); med devices; pharma

• Lead cross-functional teams and project management; Root Cause Analysis and Risk Analysis

• Effective Communicator, interact well with all levels of management and personnel

• CAPA; MRB

Career History

Quality Manager - Consultant 2023

Bombardier Learjet, Inc.: manufacturer of high precision aircraft components Role Description:

• Oversee and lead the Quality Team. Establish and maintain the Quality Management System.

• Responsible for administering the Company's Quality Program in accordance with Customer, AS9100, AS9102 and ISO9001 requirements.

• Act as the primary customer contact for escapes and Quality issues.

• Ensure process and product compliance through appropriate reviews and approval of work products.

• Ensure all certifications and training are performed in compliance with and adhering to the company, industry, and regulatory requirements.

• Issue and monitor System Corrective Action.

• Oversee and administer Internal Audit Program.

• Schedule and oversee Customer and Registrar audits for Quality System approval.

• Ensure procedures, processes, and controls are maintained for the creation and retention of required Quality records in support of regulatory and customer requirements.

• Lead the FOD prevention program. Coordinate calibration services. Quality Assurance Manager – Consultant 2023

Origin Biologics: manufacturer of allografts

Role Description:

• Managed Quality System.

• Managed external (FDA, Customers) and internal audits to ensure compliance.

• Designed Quality Plan to improve KPIs, identified Quality problems and recommend corrective action.

• Improved SOPs and WIs – Excellent technical writing skills.

• Expanded Quality Department – reviewed quality inspection personnel qualification and training requirements, hired and managed Document Control Administrator and Inspection Specialist.

• Oversaw release of FG – verified products were according to Quality specs.

• Reviewed technical documentation such as Validation and Risk Analysis reports.

• Provided leadership and guidance to Quality staff as well as input to management on process or procedural system improvements.

• Experience with aseptic processing.

Kathleen Yanakis

661-***-**** *.*******@*****.***

• Managed customers complaints (CARs).

• Selected software for better data capture and efficiency towards Continuous Improvement.

• Supervised, provided training to, and monitored performance of QA staff. Quality Systems Analyst – Consultant 2022

Amgen Biopharma

Role Description:

• Quality Assurance Management support;

• Customer complaints review;

• CAPA verification; reports closures

Sr. Manager, QA/QC & R&D 2020 -2021

SeneGence International: developer, manufacturer and seller of cosmetics and personal care products. Role Description:

• Planned, directed and coordinated Quality Assurance programs and formulated Quality Control policies.

• Instilled Quality Assurance culture by authoring SOPs/WIs and training personnel in Change Control, CAPA, Receiving Inspection, Document Creation/Revision, Document Control, Deviation, Complaints, and Disposal.

• Created and/or modified QMS Forms; cultivated dialogue with CMOs; developed Document Control function; improved communications between Ops and QC; integrated R&D changes into Change Control program.

• Investigated product discrepancies directly with Suppliers. Managed Receiving Inspection and rework.

• Supervised staff and conducted performance review. Quality Assurance Manager – Consultant 2019 – 2020 Pharmhouse

Role Description:

• Established Quality Management System for new

Cannabis Licensed Producer in Canada

Quality Assurance Analyst – Consultant 2017 – 2018 Ansell Medical Devices

Role Description:

• ISO13485 re-Certification audit support;

• CAPA management; Suppliers program support

Manager, Quality Assurance and Regulatory Affairs - Consultant 2016 California Cryobank: reproductive tissue services and stem cell laboratory Role Description:

• Oversaw QA/QC & RA Compliance for reproductive tissue service and stem cell processing in Clean Room.

• Oversaw regulatory submittals for accreditation, licensing, and maintenance of company credentials (FDA

(Tissue and Biologics), AATB, AABB, CLIA, CAP).

Kathleen Yanakis

661-***-**** *.*******@*****.***

• Acted as Company's liaison to regulatory/accrediting agencies.

• Managed internal, external, and third party audits (including branches and Contract Service Providers).

• Managed compliance activities related to international business.

• Oversaw Document Control including review and approval of Quality policies and procedures.

• Oversaw the CAPA program.

• Developed process improvement measures to ensure Operation's efficiency and effectiveness.

• Managed Safety. Supervised staff and conducted performance review. Manager, Quality Assurance 2012 - 2015

PL Developments: manufacturer of private label and branded pharmaceutical products. Role Description:

• Using statistical data analysis (Minitab), generated process capability analyses (including Control charts) for all formulations from thirteen families of products.

• Provided quality review of batch records and analytical data; introduced additional quality metrics to improve outcome consistency. Performed trend analyses on stability time point data.

• Ensured quality and compliance requirements (FDA, HACCP, ISO9001, 21 CFR Part 210) were met effectively and efficiently in support of corporate objectives.

• Optimized production lines and implemented a risk-based approach to enhance GMP in manufacturing ops.

• Assessed deviations, investigated OOS, and managed timely closure of CAPA.

• Managed Annual Product Review project consisting of thirteen families of products (8-10 people team).

• Oversaw Change Control processes.

• Conducted studies to demonstrate Validation state of manufacturing processes. Supervised development of Validation methods.

• Authored and edited several SOPs addressing quality and regulatory requirements. Trained staff to ensure SOPs' implementation in support of GXP activities.

• Led internal GXP audits.

• Experience with problem-solving models (Flow Chart, Fishbone Diagram, Pareto Chart, Histogram, Scatter Diagram); corrective action implementation, and process improvement (Root Cause Analysis, 5 Whys).

• Knowledge of principles and practices of Lean manufacturing.

• Established collaborative relationships with customers to ensure quality and compliance matters were addressed in a timely and transparent manner.

• Instituted and chaired monthly QA Right-First-Time meetings; analyzed quality trends and continuous improvement opportunities.

• Managed Safety. Supervised staff and conducted performance review. Co-Chair 2009 - 2010

Association of Energy Engineers, Southern California Chapter Role Description:

• Co-chaired Annual Conference. Actively sought out guest speakers. Sponsorships recruitment. Kathleen Yanakis

661-***-**** *.*******@*****.***

Sr. Design Assurance Engineer, R&D Dept. 1998 - 2009 St. Jude Medical, CRMD: R&D and manufacturer of Class III medical devices Role Description:

• Led the development and application of Design and Process FMEA. Generated comprehensive reports as part of the Risk Management Plan.

• Insured, in consultation with R&D and Manufacturing engineering teams, that compliance requirements of new and revised designs were met.

• Coordinated activities with R&D and Manufacturing for satisfactory closure of CAPA.

• Compiled data for Design History files and Device Master records for submittals to domestic and international regulatory agencies.

• Knowledge of:

• QSR 21 CFR Part 820, ISO 14971, ISO 13485, QMS ISO 9001, MDSAP, EU MDR 217/745.

• Class III medical devices' manufacturing environment requirements (cGMP).

• Audit requirements for manufacturers of Class III medical devices. Education

M.S. Engineering Management Cal State University Northridge B.S. Engineering Cal State University Northridge

B.S. Biology McGill University, Canada

B.A. Letters & Sciences Montreal University, Canada Certifications

ASQ CQA

Six Sigma Green Belt

Language

French (fluent r/w/s)

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