Jeanette M. Keating

13 Preserve Way

Saratoga Springs, NY 12866

260-403-8357

Jeanette.keating@gmail.com

 

Professional Experience and Goals: I have over 15 years of experience in the pharmaceutical, medical device, and combination device industries. My educational background and diverse experience in manufacturing, product development, quality assurance, and research has given me great exposure and insight to overall business needs.  I am seeking a Quality Management role where I can utilize my leadership, decision–making, coaching, and multi-tasking abilities.

 

Industry Experience:

C.R.BardAugust 2012-current

Quality Engineering Manager

-Supervise an Analytical Lab Manager, two QEs, two QC technicians; oversee the Analytical and microbiology lab operations, QC functions, as well as quality engineering management in support of a combination drug/device product.

-Incorporated CFR Part 210/211 regulations into the Quality System; successfully passed a PAI inspection in December 2013

-Responsible for the Quality management and metrics within the product line.  Drive action for trends and non-conformances.

-Responsible for review of all protocols, reports and validations relating to product lines, change control, in-process and incoming inspections, final review and release of drug-coated product based on analytical and functional test criteria, participation in third party audits, decision making with respect to non-conformance investigation/resolution, and managing personnel issues

-Develop headcount models, oversee spending, equipment purchases and ensure maintenance of business is executed

 

 

Unilife Inc.

Operational Quality ManagerMarch 2012-June 2012

Key Accomplishments/Responsibilities:

-Supervise and direct a team of 14 QC Inspectors, QC Supervisors and a Quality Engineering Technician

-Improved work flow, documentation review and implemented lab standards

-Responsible for incoming, in-process and final product testing and calibration of equipment within the lab

-Root cause investigations and corrective action implementation of nonconformances

 

Zimmer Inc. (Orthopaedics)August 2004-March 2012

Principal Research EngineerTrauma Division, Warsaw, IN

Quality Assurance ManagerSurgical Products Division, Dover, OH

Senior Product Development EngineerSurgical Products Division, Dover, OH

Key Accomplishments/Responsibilities:

-successfully developed a new test method for product performance assessment with no questions from the FDA

-completed testing of a new technology screw to support a 510k submission

-present external research proposals to the Research Sub-Committee, interact with surgeons and manage external research studies

-represent Product Development and Research in project teams, risk management, and design assurance processes

-initiated implementation of Six Sigma statistical analysis methods and statistical process controls

-supervise and direct 17 staff members (Engineering, calibration, validation, technicians)

-establish inspection specifications, problem solving and root cause investigation

-vendor approval, auditing and issue resolution

-improved test and measurement methods to reduce measurement error in production non-conformances

-initiated QA/Product Development/Manufacturing reviews of critical dimensions prior to manufacturing transfer

-CAPA management and improvements within the QA department

-conduct Lean events/Six Sigma projects within the QA department

-Quality management representative for various third party audits

- Project Leader for Zimmer’s Switzerland facility gentamicin loaded bone cement product line launch

-learned to read and write in German in 6 weeks to facilitate the product development process

-member of the Power-Mix cement mixing system and Pain pump development teams

 

Vyteris, Inc., Fair Lawn, NJ (Pharmaceutical and Device startup)June 2001-August 2004

Product Development Engineer

Key Accomplishments/Responsibilities:

-designed patches for future iontophoretic transdermal drug delivery platforms

-worked with vendors to improve formulation and manufacturing processes for electrically conductive ink

-reduced setup time from 80+ hours to 2 hours

-worked with outside vendors performing facility audits, resolve manufacturing scale-up issues, establish packaging and labeling operations with a contract manufacturer, and created receiving specifications

- wrote protocols, test summaries, vendor qualifications and quality procedures

-was the product development lead engineer for the drug/patch component of the system

-subject matter expert for the design history and patch performance during FDA PAI audit

-managed wear study to address end-user safety issue(s) of previously designed patch

-supervise and train an Industrial Designer

-project leader responsible for organizing a Phase I clinical study of a device/drug in our development pipeline

-prepared and participated in marketing Focus groups for the LidoSite product

 

Wyeth Ayerst Research (WAR) Pearl River, NY (Pharmaceutical)August 1998-June 2001

Instrument Specialist

Key Accomplishments/Responsibilities:

-designed components for our custom automation robotics used in high-throughput screening of drug compounds

-wrote programs using Visual Basic code for robotic movement control

- conducted reliability (validation) testing for our automated components and systems (custom and commercial)

-system administrator of our ProE LAN

-created a custom database to track all “in-process” projects using MS Access and VBA

-documented the validation of a radio telemetry system used for drug safety assessment testing at WAR

-responsible for cardiac monitoring via telemetry, for drug safety assessment

 

Osteonics, Inc., Allendale, NJ (Orthopaedics)February 1996-August 1998

Project Leader

Key Accomplishments/Responsibilities:

-supervised a 36 member department consisting of shipping/receiving, customer service and loaner pool are personnel

- wrote and executed protocols to justify the lowering of radiation dosage to minimize material surface wear

-subject matter expert for testing and justification of the lower radiation dose during a FDA audit

-justified the acquisition and validated capital equipment that increased capacity by 200%

-validated vacuum sealing packaging equipment

-developed testing procedures and composed and conducted process validations

-designed new packaging components

-improved microbial monitoring processes of a Class 100,000 cleanroom and fielded questions pertaining to the method changes during an FDA audit

-company trainer for GMP and ISO9000

 

Education:

Rutgers, The State University of New Jersey, New Brunswick, NJ and University of Medicine and Dentistry of New Jersey, New Brunswick, NJ

Master of Science in Biomedical Engineering, January 1996; coursework specialized in Biomechanics/Biomaterials

 

Worcester Polytechnic Institute, Worcester, MA

Bachelor of Science in Mechanical Engineering with an interest in Biomedical Engineering; May 1993

 

Training:

Lean/Six Sigma Black Belt (2007), Management Skills Training [Resolving Conflict, Managing Performance Problems, Rapid Decision Making] (2006), Zimmer OSP Sales Training (2005), Design of Experiments (2005), FDA Systems Inspections (2002), ProEngineer and System Administration (2000)

 

References:

Furnished upon request