Medical Device Quality

MICHAEL CARLSON

** ***** **., ***********, ** ***07

413-***-**** ********@*****.***

PROFESSIONAL SKILLS SUMMARY

Motivated QA/QC Site Director with over 17 years of fast paced contract laboratory and manufacturing experience in the pharmaceutical, biotech, and medical device industries. Management Experience: Directed Site of 100 employees

Reported to the CEO within a private equity environment

Managed QA team of 10 – 15 members

Managed quality needs of over 400 US/European clients

Managed quality systems for GMP, GLP, ICH, ISO 17025 and ISO 9001

Managed 30 – 40 client facility quality audits per year Regulatory Experience Lead company in 6 FDA audits, 2 EMA audits, 8 QP audits, and 6 ISO certification audits

Supported product approval and annual regulatory needs for over 400 clients

Lead company in regulatory response to FDA inspection observations Laboratory Experience Review and approval of method development and validation efforts for analytical and micro assays

USP/EP microbial and analytical method procedure review

Supported stability protocol development and execution

Quality oversight for over 200 GLP studies/year

Lead validation efforts for facility, lab equipment, and processes Manufacturing Quality support and disposition of over 100 clinical/commercial aseptically filled products

Lead process/equipment validation efforts for aseptic processing suite

Managed product complaints, investigations, and process improvements PROFESSIONAL EXPERIENCE

AVISTA PHARMA SOLUTIONS, Agawam Massachusetts

Contract Development and manufacturing organization (CDMO) formed through the strategic carve-outs of the CMC business of Array BioPharma, Inc. and contract services business of Scynexis, Inc. Site Director 2015 – 2016

Lead and directed 100 employees through an expansion of facility and organization including:

Board Presentations Organizational Evaluation & Restructure

Capital Budgets Laboratory Expansion/Design Project

Reduced Revenue Recognition Time IT Modernization MICROTEST LABORATORIES, INC.,/ ACCURATUS LAB SERVICES, INC., Agawam Massachusetts Contract Testing and Manufacturing for Medical Device and Pharmaceutical Industry Director of Quality 2001 – 2015

Successfully implemented, managed, and improved the quality systems of the contract laboratory and contract manufacturing services including:

CAPA Complaint Handling

Internal Audits Change Control

Management Review Environmental Monitoring

Material Control/Management Document Control

Team Quality Management System integration as part of an acquisition:

Lead site implementation of MasterControl Lead integration of multi-site quality systems MICHAEL CARLSON PAGE 2

Achieved company regulatory compliance requirements:

Lead 4 FDA audits with no 483s Lead DEA and Radiation Control audits

Chaired FDA observation response team Lead QP audits resulting in clinical product release Lead over 300 client audits resulting in improved client business and quality relationships:

Improved audit hosting efficiencies Audit response generation/resolution

Quality Agreement Creation/Collaboration Developed customer relationships Lead company review, approval, and resolution of nonconforming events through the use of root cause analysis and risk evaluation.

OOS investigations Deviation Events

Environmental excursions Out of Tolerance (calibration)

Invalid Assays Out of Trend Events

Lead batch record review, approval, and product release of over 100 different contract drug products to achieve client’s clinical/commercial timelines.

Efficient batch record review Supervised materials management process

Specification generation approval GMP compliance auditing

Client batch record review resolution Certificate of Analysis generation Increased companywide GMP knowledge and improved company compliance efforts through interactive training and quality metrics.

Companywide quality metric communication Reduction of outstanding noncompliance reports

Reduction of nonconforming events Decreased noncompliance report closure time

Developed interactive annual GMP training Promoted QA team collaboration Developed, implemented, and improved the equipment control program and validation efforts

Equipment continuous monitoring systems Aseptic media fills and sterilization validations Regulatory Associate 1999 – 2001

Assisted the company president with quality and regulatory improvements for medical device clients. Managed and improved the medical device accelerated aging testing program, the ethylene oxide testing of sterile medical devices and the total organic carbon testing of water samples. ALKERMES, INC., Cambridge Massachusetts

Sustained Release Injectables

Validation Technician 1997 & 1998

Generated over 20 IQ/OQ/PQ validation protocols on production equipment for new facility. Executed installation and operational protocols for cold rooms, isolators, and controlled temperature chambers, including temperature mapping and data analysis.

CROSSPOINT ENGINEERING Westwood. MA.

Engineering Services 1996

Validation Technician

Executed installation and operational protocols for cold rooms, isolators, and controlled temperature chambers, including temperature mapping and data analysis. Presentations

Process Validation for the Medical Device Industry, New England Biomedical Discussion Group, ASQ Biomedical Division – Case Study: Radiation Sterilization Validation. May 23, 2000, Needham, MA

Batch Records for Clinical Manufacturing, MicroTest Seminar Series. March 2011, Dedham, MA

Environmental Monitoring Overview, MicroTest Seminar Series. October 2011, Dedham, MA Education

Bachelors of Science in Biology; University of Massachusetts, Amherst, MA

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