Quality Assurance Systems

Lewis Blair

Greater Los Angeles Area 617-***-**** ***********@*****.***

Quality Assurance Director QA Manager CAPA SME Quality Systems Expert

Over 20 years of Quality Assurance experience includes Director of Quality Assurance, Project Manager, Batch Record Disposition Manager, and other leadership positions. Extensive background and documented success in Quality Systems development and implementation within the pharmaceutical and medical device industries. Recipient of multiple awards for innovation, project management, and team leadership.

OVERVIEW: Combine an advanced technical and engineering background with team and program leadership skills to achieve perennial success in QA objectives. A career-long commitment to Quality Systems, CAPA Programs, CMO and Contract Lab Management, and Continuous Improvement excellence, including Quality Core Values of Accuracy, Consistency, Efficiency, and Traceability.

Solution Innovation successes includes extensive CAPA Remediation Program Management for DePuy Synthes, migration from paper to electronic, Part 11 compliant documentation control at Vertex Pharmaceutical. QA Unit lead for GLP compliance. Proven record of creating and maintaining QMS compliant with: FDA 21CFR820 / 210 / 211 / 803 / 806 / 58 / 4 / 11, ISO 13485, ISO 14971, and ISO 9001.

Professional Experience

ADAMSON ANALYTICAL LABORATORIES, A Tentamus Company – 2/2024-2/2025

Regional Quality Assurance Manager (Promotion) – 8/2024-2/2025

Quality Supervision of four Tentamus, West Coast laboratories.

Quality Assurance Manager – 2/2024-8/2024

Quality Supervision and Management for Adamson Analytical Laboratories

CONSULTANT – 2020-2023

AMGEN – Combination Product - Thousand Oaks, CA – 10/2022-10/2023

Quality Assurance Manager

Provided Quality Oversight of Combination Products’ development, with particular attention to Test Method development and approval, ensuring regulatory, Quality Systems, and GMP compliance.

Santa Cruz Nutritionals – Nutraceuticals – Santa Cruz, CA – 03/2022-07/2022

Quality Systems Manager

Responsible for the integration of all systems feeding directly into manufacturing. Improved the timely release of Production Batch records from one day to one-week prior to production. Set up global Corrective Action, to align all department functions feeding into manufacturing.

AMGEN – Combination Products – Thousand Oaks, CA – 11/2020-12/2021

Quality Assurance Manager

Quality Assurance representative ensuring regulatory, Quality Systems, and GMP compliance

FULL TIME EMPLOYEE (FTE) – 2019-2020

KITE, A Gilead Company – March 2019-October 2020 – Company Lay-off

Disposition Manager

Final decision on batch record disposition of T Cell lots for shipment to clinic for patient re-infusion.

Maintained a 100%, on-time review and disposition of batches, with a daily disposition of three to six batches.

Extensive deviation review directly contributing to my disposition decision, involving large cross-functional interaction.

Maintained Quality Metrics, with weekly presentations to the Quality Lead Team.

Received multiple awards for Teamwork and Performance Excellence.

CONSULTANT – 2013-2018

Quality Assurance Specialist Program Manager Quality Systems’ Lead

Consult with client companies to provide expertise and support on quality assurance, regulatory compliance, and related matters. Met and exceeded requirements in every contracted position, including the following:

Quality Management System Lead, Shire (Pharmaceutical & Medical Device), 3/2018-10/2018 – Served as Change Control Specialist for MasterControl migration to Veeva Vault (Veeva Vault Business Administrator). Used QMS remediation to reduce 60K document count via end-to-end process development.

Program Manager/Risk Management Remediation, DUSA (Pharmaceutical & Medical Device), 6/2017-12/2017 – Directed engineering development for dermatology product line. Lead DFMEA remediation in response to FDA 483s. Oversaw CMO management of design and assembly houses.

Change Control, Risk Management & CAPA Specialist, Spectranetics (Medical Device), 4/2017-6/2017 – Managed cross-functional coordination of CAPAs that required FMEA remediation. Drove CAPA program remediation of 196 CAPAs resulting from FDA inspection 483s.

Quality Management System Specialist, Lake Region Medical (Medical Device CDO/CMO), 10/2016-3/2017 – Conducted ISO 13485:2016 gap analysis, remediated Customer Complaint intake and reporting, and created a program for standardization of Quality Management Systems across 31 sites.

Quality Assurance Consultant, Acceleron Pharma (Pharmaceutical), 4/2016-9/2016 – Performed executed batch record review and lot release for clinical trial of cellular growth product. Remediated Quality Systems.

Change Control/CAPA Quality Assurance Consultant, Fresenius Medical Care (Medical Device), 7/2015-4/2016 – Harmonized CAPA and Quality Systems across 8 North American and Canadian sites. Oversaw FMEA management and created process to standardize for 21CFR806 objective reporting determination.

Quality Assurance Consultant, Shire, 2/2015-6/2015 – Completed review and remediation of Quality Systems processes; remediated deviation, CAPA, and change control backlog.

Quality Assurance Consultant, Acorda Therapeutics (Pharmaceutical), 10/2014-1/2015 – Planned and executed comprehensive batch record review.

Quality Assurance Design Control, CAPA, Change Control SME, J&J DePuy Synthes, 3/2013-8/2014 – Remediated 600+ audit CAPAs for Verification of Effectiveness and FMEA remediation objective.

FULL TIME EMPLOYEE (FTE) – 1996-2013

BRAINTREE LABS, INC. – 1/2012-1/2013 – Company Lay-off

Director of Quality Assurance

Brought on board to create and lead a Quality department, including its Quality Systems compliant with FDA 21CFR820. Recruited, hired, and managed team of up to 8, including QA Investigations Manager and Training Manager. Set up Customer Complaint process and monitored all CAPA, Complaint, and QA System requirements.

Led team in producing multiple quantifiable improvements: significantly increasing production yield, reducing manufacturing downtime incidents, decreasing manufacturing downtime, raising daily production, and reducing number of Planned Deviations.

Created and implemented training program that included hiring Training Manager and developing ongoing cGMP training to meet 21CFR210/211 requirements.

ENZYMATICS – Beverly, MA – 1/2011-12/2011 – Company Lay-off

Director of Quality Assurance

Recruited and hired to build a Quality department, including Quality Systems compliant with FDA 21CFR820. Hired and led team of up to 5, including engineers and document control team members. Developed documentation and configuration management processes

Created QA Unit to ensure GLP compliance.

Created and executed Quarterly Management Review requirements, advocating for their importance and benefit on an organization-wide basis.

VERTEX PHARMACEUTICALS – Cambridge, MA – 2/2005-1/2011

Project Manager, QA Unit Lead, and Quality Systems Development (2008-2011)

Senior Quality Assurance Specialist (2007-2008)

Documentation Manager (2005-2007)

Progressed rapidly through increasing responsible positions with a billion-dollar company. As Project Manager, directed application transition and change management initiatives. As Senior QA Specialist, oversaw supplier auditing and managed supplier communications via encrypted server. As Documentation Manager, reviewed technical files for 510(k) submissions.

Created Lotus Notes documentation control and eventually led the scale-up from Lotus Notes to QUMAS for document workflow management. Developed the change control process in Trackwise.

Part of QA Unit for control of lab experiments and documentation for small molecule investigation.

Earned 4 VOCAP Awards (Vertex Outstanding Contribution Award Program):

-VOCAP: Project Management of multi-site, quality system alignment.

-VOCAP: Migration to Part 11 complaint documentation control.

-VOCAPs (2): Development of the Documentation department.

BOSE CORPORATION – Framingham, MA – 5/2003-1/2005

Configuration Analyst Manager Documentation Control Manager

Supervised, trained, and led team of 9 Configuration Analysts (CAs) as well as Documentation Coordinators. Developed and modified processes to achieve productivity, efficiency, and information management goals.

Drove significant improvement in transparency, communications, and cross-functional expectations by defining an RACI that encompassed 29 roles and over 300 tasks.

Increased productivity from 180 to 250 ECNs per month by developing and implementing an electronics ECN process.

PLANAR SYSTEMS (formerly DOME Imaging Systems) – 2/1996-4/2003

Quality Assurance Documentation Manager (2000-2003)

Project Manager (1999-2003)

Engineering Administrator/Quality Assurance (1996-2003)

Hired as Administrator and earned 2 subsequent promotions during the company’s expansion period. Assembled, trained, and led Sustaining Quality Engineering team in overseeing CMOs. Harmonized Quality System and documentation requirements across 3 sites in Massachusetts, Florida, and Oregon. Created assembly and QMS documentation for ISO 9001 and ISO 13485 certifications.

Played critical role in the company’s ongoing growth by recommending and introducing a full-scale Project Management function, including suppliers, CMOs and CDOs, regulatory compliance and certifications, QMS development, and regulatory submissions.

Received ISO 9001 and ISO 13485 Certifications as ISO Management Representative and Lead Internal Auditor. Developed the CAPA system in Lotus Notes.

Facilitated paper-to-electronic transition by implementing 21 CFR Part 11 compliance for Lotus Notes.

Education & Credentials

Bachelor of Science in Mechanical Engineering (BSME) – University of Hartford – Hartford, CT

Awards include:

o1st Place in the Freshman Competition, and

o1st Place in the Senior Design Competition

President of the Kappa Mu Engineering Honor Society

Certifications/Licenses – Certified ISO Lead Auditor, Royal Accreditation Board (RAB)

oAuditing Program development

oInternal Auditing

oExternal Auditing

oSupplier Auditing

Technology Summary –

QualTrax (Administrator)

Veeva Vault (Business Administrator),

Lotus Notes (Senior Developer),

Oracle,

AGILE,

QUMAS,

Trackwise,

MasterControl,

Teams and Miro, and

Advanced proficiency in the Microsoft Office Suite,

Community Involvement –

President & Artistic Director, Lexington Youth Summer Theatre (LYST), 21 years,

Big Brother, Big Brother Organization of Eastern Massachusetts, 10 years.

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