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Manager Quality

Location:
Sonoma, California, 95476, United States
Posted:
January 28, 2018

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Resume:

CAROL J. BRAMLETT

OBJECTIVE:

To use my TQM, ISO and SPC experience to inspire compliance and continuous process improvement.

PROFESSIONAL SUMMARY

Highly effective quality systems professional with excellent oral and written communication skills. American Society for Quality (ASQ) Certified Quality Auditor (CQA) with extensive current Good Manufacturing Practice (GMP) and ISO 9001 compliance development experience. Proven problem analysis and decision making skills. Extensive project management experience with history of meeting deadlines and managing multiple projects. Motivated to instill quality improvement practices in every operational area using quantitative measures and statistical analysis.

SELECTED ACCOMPLISHMENTS

• Developed complete ISO compliant quality system process and SOP for variety of manufacturers.

• Hosted 9001 certification and surveillance audits with zero major observations.

• Managed international supplier audit program including auditing in China, Japan and Europe.

• Developed and managed supplier auditing program including 13 contract manufactures and over 200 suppliers;

• Managed statistical process control (SPC) program implementation in component manufacturing processes;

• Developed and delivered engaging quality compliance and improvement training;

• Managed computer validation of a temperature monitoring system per FDA Part 11 requirements;

• Oversaw quality system for manufacturing of pressure vessel regulators, TENS/NMS devices and hearing aids.

PROFESSIONAL EXPERIENCE:

Consultant – GMP and ISO Quality System Development, Training and Auditing 2010-Current

Led US GMP and ISO inspection readiness effort. Host surveillance and re-certification audits. Including working as Validant consultant placed at Johnson&Johnson/McNeil as part of their comprehensive FDA consent decree readiness audit team and Roche/Genentech new Combination Devices US FDA GMPs.

BioMarin Pharmaceutical, Inc. - Novato, CA 2008-2009

Senior Manager, Corporate Compliance

Oversaw global supplier GMP compliance audit program. Developed and executed global auditing strategy to support corporate quality initiatives. Planned and administered $500K auditing program budget.

Merck KGaA, Merck Generics Group - Potters Bar, Hertfordshire UK 2007-2008

Sr. Compliance Auditor – European Region

Six-month overseas assignment to manage and execute GMP compliance audits of API manufacturers and 3rd party contract manufacturers within the European Region.

Merck Generics Group, Dey L.P. - Napa, CA 2005-2008

Sr. Compliance Auditor

Responsible for developing and managing internal and external GMP compliance audit program.

Sanofi-Aventis – New York, NY 2003-2005

Sr. Manager GMP Compliance

Responsible for developing and managing a GMP supplier audit program for North America. Duties involved scheduling and conducting supplier GMP compliance audits and tracking audit responses to closure. Responsibilities involved 13 contract manufacturers and hundreds of suppliers including: API and critical excipient manufacturers, contract laboratories, contract packagers and suppliers of packaging components and printed materials.

Schering-Plough Pharmaceuticals – Springfield, NJ 2002-2003

Compliance Manager Corporate Quality Audits & Compliance

Responsible for conducting regulatory compliance audits of worldwide manufacturing and distribution facilities as assigned. Duties included evaluating efficiency of operations, performing risk analysis, reporting observations to executive management and following up to ensure implementation of effective corrective and preventive action.

AmerisourceBergen - Integrated Commercialization Solutions, Inc. 1999 - 2002

Dallas, TX and Louisville, KY

Manager, Quality Assurance

Responsible for ensuring operations are compliant with the FDA GMP, Prescription Drug Marketing Act (PDMA) and DEA requirements. Coordinated crucial aspects of promoting third party logistic services with numerous pharmaceutical and medical device manufacturers. Duties involved facilitating compliance issues in all operational departments and training Associates on procedures and continuous process improvement.

Bledsoe Brace Systems – Grand Prairie, TX 1997 - 1999

Quality Systems/Regulatory Affairs Manager

Responsible for ensuring compliance with the Food and Drug Administration (FDA) Quality System Regulation (QSR), CE marking requirements and obtaining ISO 9001 certification.

Empi, Inc. – Shoreview, MN 1996 - 1997

Quality Systems Specialist

Responsible for implementing an ISO 9001 and QSR compliant corporate quality system. Developed and conducted new employee and annual quality system overview classes and internal auditor certification training.

Tescom Corporation – Elk River, MN 1994 - 1996

Corporate Total Quality Management (TQM) Facilitator

Responsible for integrating TQM concepts into operations of three divisions. Designed and delivered training on ISO requirements for management and new employees.

Ascom Audiosys, LTD - Maico Hearing Instruments – Edina, MN 1993 - 1994

Regulatory Affairs/Quality Assurance Manager

Duties included conducting system audits, leading GMP compliance audits, and coordinating FDA submissions.

Baxter Healthcare Corporation - Paramax Division – Irvine, CA 1985 - 1988

Quality Leadership Coordinator

Responsible for coordinating a corporate sponsored quality improvement training program for 400 division employees. Duties involved: maintaining training budget, equipping training classroom, scheduling train the trainer sessions, and conducting several classes of the 20 hour training program.

Regulatory Affairs Analyst

Assisted in all aspects of formulating and administering regulatory policy pertaining to medical device manufacturing. Responsible for facilitating and conducting GMP compliance.

Searle Pharmaceuticals – Mt. Prospect, IL 1982 - 1985

Documentation Center Supervisor

Responsible for determining and supplying division documentation needs in accordance with GMP's. Duties included: issuing batch documentation, supervising batch record review and maintenance, authorizing batch release, and facilitating FDA audits.

Quality Control (QC) Supervisor

Supervised four QC technicians on a two-shift rotation for ten product lines.

CREDENTIALS:

Wheaton College, Wheaton, IL - Northern Illinois University, Dekalb, IL – B.S. degree in Biology with honors

St. Thomas University Graduate School of Business - Quality Management Certificate; Trainer Skills II Series.

*************@*****.*** Page 1 of 2 Cell: 707-***-****

P.O. Box 2125

Sonoma, CA 95476



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