Richard A. Russell

**** ********* ******; Cuyahoga Falls, OH 44221

Home: 330-***-****; Cell: 330-***-****; E-mail: acebw3@r.postjobfree.com

Linked In: www.linkedin.com/pub/richard-russell/7/874/67/

Dear Hiring Professional,

I am interested in obtaining a technically challenging position within a reputable organization that seek a

self-motivated leader with the aptitude to enhance the efficiency and effectiveness of the organization.

My attached resume outlines my credentials that appear to be a great fit for this position.

Listed below is a brief overview of my recent professional career:

Within my most recent role as the Supervisor of Environmental Monitoring / Microbiology, I have been

heavily involved with many high level managerial responsibilities in addition to the day to day

supervision duties. These responsibilities included the management of numerous projects that were

critical to the operation of the business, serving as a SME for regulatory audits and developing sustainable

processes / procedures utilizing quality management principles (e.g. LEAN, Six Sigma, Systems

approach, ISO 9000 family, FMEA) to improve the efficiency and effectiveness of the department. This

role also required significant interactions with high level management involving critical, high impact

decision making for the organization. In addition, I have received consistent commendations for

proactively assuming duties of the vacated Associate Director role within the group, consistently meeting

or exceeding deadlines and developing the talent of direct reports.

Prior to being selected for this management role, I worked in the Process Validation department as a

Physical Monitoring Technician II. Within this role, I was responsible for identifying and remediating

inefficiencies and serving as the primary change management and investigation specialist within the

group resulting in the optimization of test methods for efficiency while ensuring compendial standa rds

were maintained. Furthermore, this role required my project management leadership of Validation

protocols efforts (IQ/OQ/PQ) for facility qualifications, equipment qualifications and unique

qualifications for the manufacturing facility.

With my skill set and proven track record, I believe I can be a valuable addition to your organization. If

you determine that my qualifications match your requirements, please call me at 330-***-**** to

arrange an interview. Thank you for considering my credentials.

Respectfully Yours,

Richard A. Russell

Page 1 of 1 – Cover Letter

Richard A. Russell

3369 Pendleton Street; Cuyahoga Falls, OH 44221

Home: 330-***-****; Cell: 330-***-****; E-mail: acebw3@r.postjobfree.com

Linked In: www.linkedin.com/pub/richard-russell/7/874/67/

PROFESSIONAL OVERVIEW

Organized, effective and quality minded individual with proven ability to lead quality operation teams,

develop departmental training programs, design teams to uphold quality standards, optimize processes

and meet deadline expectations. Extensive experience of quality systems, complex data set trend

analysis, microbial test methods, technical writing, interpreting complex documentation, direct audit

interaction and engaged performance management of direct reports.

CORE SOFT SKILL COMPETENCIES

Strong skills in organizing workflow, ideas, Excellent communication / interpersonal skills

Quick learner and highly adaptable to change

materials, people

Identifying talent, engaged coaching / Works well under pressure to meet deadlines

Proven ability to identify, analyze, solve

mentoring

Excellent leadership, performance problems and make sound quality minded

management and project management skills decisions

Committed to providing total quality work Highly reliable self starter; can be counted on

Willingness to take charge in difficult to complete assignments

Responsible, dependable, punctual, ethical

circumstances and accept accountability

PROFESSIONAL EXPERIENCE

Environmental Monitoring (EM) / Microbiology Supervisor; Boehringer-Ingelheim: (2007- 2014)

Managed, coached and led over twenty direct reports within the Quality Operations unit of a critical

support group responsible for the execution of active viable, non-viable particulate (NVP) and WFI

sampling (Bioburben, LAL, Particulate) plans in a large scale manufacturing operation.

Developed and headed Environmental Monitoring Performance Qualification (EMPQ) efforts for new

facilities and facility upgrades, analysis of complex data sets and finalizing qualification package.

Conceptualized, designed and standardized risk based approach development and maintenance of site

selection (NVP, viable air, surface derived viable, passive viable, WFI) locations for all facilities.

Conducted independent area management review /approval of complex investigations, CAPA, change

control proposals, procedural revisions, protocols and audit responses. Effectively managed all

departmental obligations to ensure expected timelines were met.

Active member of the Environmental Action Committee, Microbiology CAPA board and

departmental representation during Failure Modes and Effects Analysis (FMEA) projects.

Presided as Subject Matter Expert (SME) for customer and regulatory agency audits.

Redesigned metrics resulting in numerous process improvements and business enhancements.

Managed EM Quality System Element resulting in identification of process related gaps from

regulatory governing requirements (e.g. 21 CFR Parts 11 and 210, ISO, EudraLex, USP, Guidance for

Industry, USP, ICH) and development of process improvements utilizing quality management

principles (e.g. LEAN, Six Sigma, Systems approach, ISO 9000 family, FMEA).

Served as EM management presence across the organization. Responsible for timely and accurate

decision making, diplomatic collaboration with all facets of quality and operation groups.

Forecasted departmental headcount needs, budget forecasting and direct interviewing/ hiring / firing.

Physical Monitoring (PM) Technician II; Boehringer-Ingelheim: (2004 - 2007)

All duties listed in PM Technician experience section.

Served as SME departmental representative for customer and regulatory agency audits.

Presided as primary administrator on the Part 11 compliant controlled pressure monitoring system.

Served as ad-hoc group leadership.

Page 1 of 2 - Resume

Richard A. Russell

3369 Pendleton Street; Cuyahoga Falls, OH 44221

Home: 330-***-****; Cell: 330-***-****; E-mail: acebw3@r.postjobfree.com

Linked In: www.linkedin.com/pub/richard-russell/7/874/67/

PROFESSIONAL EXPERIENCE

PM Technician; Boehringer-Ingelheim: (2000 - 2004)

Performed NVP, Clean Steam (Bioburden, LAL, Particulate), Nitrogen, HEPA Filter Integrity and

HEPA Filter Velocity testing.

Monitored and responded to out of specification alarms on automated Temperature, Humidity and

Pressure systems.

Authored and managed numerous post commissioning process validation protocols (IQ/OQ/PQ) and

finalized reports for new facility qualification, existing facility upgrades and new equipment.

Initiated process deviations, change control requisitions and CAPA. Identified and implemented

process/efficiency improvements to streamline and strengthen processes.

Component Preparation Technician; Boehringer-Ingelheim: (1999 to 2000)

Prepared components and equipment utilized for aseptic filling operations.

EDUCATION

Malone College; Canton, Ohio The University of Akron; Akron, Ohio

Bachelor of Arts: Minor in Management Chemical Engineering concentration

Graduation Date: 08/18/2006 /Transferred to Malone College

TECHNICAL TRAINING

21 CFR Part 11 - Computer System Validation; Management Development Program; College

FDA Compliance Specialist - Computer of Business Administration - University of

System Validation Nebraska Omaha

21 CFR Part 210 – cGMP; Boehringer Management Development Program -

Ingelheim (BI) Professional Training Diagnosing and Solving Performance

Change Control - Comprehensive Initiator Problems; John Carroll University - Boler

Training; BI Professional Training School of Business

Crucial Conversations – Vitalsmarts Management Development Program - Running

Commissioning, Qualifying and Validating Effective Meetings; John Carroll University -

New Facilities; Institute for International Boler School of Business

Management Development Program - Selecting

Research

Computer System Validation; Arbour Group the Best; BI Professional Training

Management

LLC Development Program -

Conducting Thorough and Effective Supervisory Skills: Working with Others; John

Investigations; BI Professional Training Carroll University - Boler School of Business

Developing Your Management Skills; Case Managing Fairly and Legally; BI Professional

Western University - Weatherhead School of Training

Planning and Scheduling Business Process

Management

Diversity - Our Competitive Advantage Improvements; BI Professional Training

Presenting Yourself and Your Ideas; BI

Training; Future Work Institute

First Line Supervisor Transformation; BI Professional Training

Quality Work Group Education in the concepts

Professional Training

FMEA (Failure Mode and Effect Analysis) of Quality Management; BI Professional

Training Concept; BI Professional Training Training

Targeted Selection Training; DDI

(Development Dimensions International)

Page 2 of 2 - Resume

Contact this candidate