JOAN S. LUTKENHAUS

2521 Stonegate Dr. N. ∙   Bedford, Texas 76021

j.lutkenhaus@tx.rr.com•   Res. (817) 268-1555 •   Cell (817) 296-2426

Proactive, results-oriented leader with extensive hands on knowledge of various Quality Management Systems including current Good Manufacturing Practice (cGMP) and ISO; Regulatory requirements including FDA, TTB, DEA, EPA, FAA, OSHA and DOT with strong organizational and general management qualifications. Expertise overseeing QA and RA requirements in multiple facility organization. Recognized for effective Regulatory oversight resulting in FDA (2005 & 2006), FAA (2006), OSHA (2006) and EPA (2007) inspections with no citations.

Collaborative, hands-on leader who engages the team and individuals across organization functions to achieve RA/QA compliance and shared goals.

Background      Over ten years experience developing competence in:

Summary:

Professional Experience

RICCA CHEMICAL COMPANY – Arlington, Texas                                                                        1991 to present

Director Regulatory Affairs/Quality Assurance (2001 to present)

Direct Quality Assurance and Regulatory Affairs compliance for four facilities including auditing, cGMP, ISO and safety training for largest independent manufacturer FDA Class I Medical Devices (In Vitro Diagnostic) and chemical testing solutions in North America.

Key Accomplishments:

·         Led company validation for sterile products in a 10K clean room using irradiation

·         Performed gap analysis for ISO 13485 2003, Medical devices -- Quality management systems -- Requirements for regulatory purposes

·         Validated Deionized Ultrapure water system to meet USP, EP and JP specifications

·         Successively served as lead company representative for FDA QSIT inspections 2003, 2005 and 2006 resulting in one 483 issued in 2003 and no other 483s; FAA 2006 inspection with no citations; OSHA 2006 inspection with no citations and EPA 2007 inspection with no citations

·         Successively served as lead company representative for Semiconductor, Pharmaceutical (21CFR 210 & 211)  and Medical Device (21CFR 820) customer audits resulting in increased business

·         Coordinated and responsible for customer audits and regulatory inspections responses and implement corrective and preventive action

·         Led the implementation into the MRP system of quality documents for Master Work Instructions, manufacturing QC release specifications, Product labels, Certificates of Analysis and MSDS

·         Developed new products to add to the product line and improvement of current product line by listening to customer inquiries.

·         Reorganized and widened the Product Stability Program to cover more products and assign more realistic shelf life assignment to current and new products

·         Initiated the validation program covering equipment, processes and Quality Control testing

·         Developed and implemented the Change Control, Change Notification, Deviations and Out of Specifications processes

·         Built on and greatly expanded the Control of Non Conforming product and MRB program

·         Instituted the Incoming Receiving inspection program

·         Increased the scope of the company wide training program for safety, technical, ISO and GMP topics over four facilities by serving as master trainer and implementing a monthly training schedule which included recruiting and training new trainers

·         Led company efforts for certification to ISO9001-2000 standard and selected the ISO Registrar Company for the initial ISO9001-2000 audit

·         Conduct data rich Management review meetings while serving as ISO coordinator and Management representative

·         Served as team leader working with the management team to develop action plans increasing customer satisfaction through analysis of customer satisfaction surveys

·         Coordinate Internal Audits and Corrective Action for four facilities

·         Consulted with managers to develop Corrective Action responses to Internal Audits and Customer audits

·         Wrote and trained on many procedures to ensure cGMP, ISO, DEA, DHS, EPA and OSHA regulations compliance for four facilities

·         Just recently developed and implemented company DEA List I Chemicals program including registration and authoring procedures to meet 21CFR 1310. Trained appropriate staff on DEA List 1 chemicals regulations.

·         Changed the customer complaints program to include all complaints, development of root cause analysis, corrective and preventive action implementation and corrective action verification.

·         Recruited and trained the QC Supervisor for Quality Assurance and Technical Service responding to customer product inquiries and capabilities

·         Increased Private Label customer satisfaction and business by coordinating product development and developing internal process to meet customer new product requirements

·         Organized Hazardous waste disposal program to meet EPA regulations and reduce cost by establishing a national disposal contract for all facilities

Quality Assurance Manager (1998 to 2001)

·         ISO 9002 coordinator

·         Wrote ISO procedures both top level and work instructions

·         Coordinated company ISO audit

·         Recruited and trained internal auditors

Administrative Chemist (1991 to 1998)

·         QC chemist Test solutions

·         QA Production work instructions

 National Environmental Testing, Carrollton, Texas

Operations Manager. • Responsible for project scheduling and prioritizing work in process. Provided technical assistance to clients and ensured client satisfaction.

Lab Supervisor • Supervised seven analysts. Ensured project turnaround times and EPA method protocols were met.

Inorganic Analyst  • Conducted inorganic analyses using ICP, CVAA, HGAA and wet chemical analysis

Core Laboratory, Dallas, Texas

Chemist II • Petroleum analysis using vacuum distillation, gas chromatography and flame photometry

Chemist I • Water analysis of waters originating from Petroleum fields

Skills

·         Excel, Word, PowerPoint and Visio

Education and Credentials

Bachelor of Science in Chemistry, Math minor • University of North Texas • Magna cum laude

ASQ Certified Quality Auditor (2000)

Quality Assurance classes at Tarrant County College

FDA Medical Device seminars sponsored by Dallas FDA

ISO9001-2000 on line training class sponsored by American Society for Quality (ASQ)

Training on conflict resolution

Web training on various topics

Authored and presented a technical paper at Pittcon Conference 2006 on “Quality Management Systems prevalent in the Spectroscopy Area”

Professional memberships

American Chemical Society (1985)

American Society for Quality (ASQ) Fort Worth section 1416 (1995)